SOW-Qiagen.docx

STATEMENT OF WORK

FOR

QIAgility/QIAxcel

1. BACKGROUND INFORMATION

The mission of the Clinical Center (CC) (defined as Warren Grant Magnuson Building (Bldg. 10), Ambulatory Care Research Facility (ACRF) and Clinical Research Center (CRC)) is to provide clinical research servicing the needs of the NIH Intramural Research Program by providing a safe and effective environment for the care and treatment of patients participating in structured biomedical research protocols. It consists of 3.5 million square feet of mixed occupancy space in three congruent buildings on the NIH campus. The Clinical Center (CC) is a 234-bed clinical research hospital. The CC employs approximately 2,000 employees, across 30 different departments. The Clinical Center Complex consists of 3.5 million square feet of mixed occupancy space in three congruent buildings on campus.

The Critical Care Medicine Department (CCMD) provides care for Clinical Center patients who have life threatening illnesses. The department is responsible for managing the medical intensive care unit, the code blue team, the rapid response team, pediatric intensive care unit, nuclear cardiology, and respiratory therapy. The department also staffs the pulmonary, cardiology, and infectious disease consult services, each several months per year.

The Department’s major responsibilities are:

· Clinical Services

· Training

· Basic and translational research

The mission of the Department is to (a) provide superb care for Clinical Center patients who may benefit from critical care services, (b) improve both understanding and management of the critical disease processes, c) train health care professionals to understand, provide, and improve critical care services.

Departmental goals include

· Organizing, developing, and maintaining a medical facility capable of providing a full spectrum of superb critical care and specialized outpatient services to the Clinical Center.

· Maintaining a consultative service to assist in the management and care of critically ill patients throughout the Clinical Center.

· Maintaining an educational and training program in critical care for therapists, nursing and physician staffs.

· Providing national leadership in directing the standards and goals of critical care clinical practice, training, and research.

CCMD Mission

To provide high quality and cost effective clinical service that meets the needs of CC patients and NIH Institutes, to facilitate the research goals of NIH Institutes and investigators, and to conduct high quality research and training in Critical Care Medicine.

2. PURPOSE

The purpose of this acquisition is the purchase of a QIAgility HEPA/UV (PC) PrioPLUS and a QIAxcel Advanced, PrioPLUS along with the appropriate consumables (QIAxcel RNA QC kit v2.0) for analysis of 3000 RNA samples from human blood samples acquired for the Critical Care non-human primate project. This equipment purchase is required for: 1) automating the creation of replicate samples of our extracted RNA from single volume aliquots (ie. creation of archival repositories of all 3000 RNA samples); 2) protection of the samples from potential environmental contaminants to ensure sample integrity and sterility; 3) automation of reaction mix steps and sample mixing for subsequent conversion of the RNA to cDNA and creation of the digital PCR reaction mixtures; and 4) high-throughput bioanalysis of the RNA samples to measure RNA integrity and RNA concentrations. Samples which have been acquired for this protocol cannot be duplicated or redrawn. Thus the integrity of the samples, and the processing steps undertaken within this research project, are of the upmost importance to both the success of this project and global public health.

3. REQUIREMENTS

The procurement of the below items. The contractor will provide the following:

· QIAgility HEPA/UV (PC) PrioPLUS (includes the QIAgility workstation, QIAgility software, system installation, required training sessions for operation of the system, a notebook computer for the operating system, and a maintenance record of performed upon the equipment)

· QIAxcel Advanced, PrioPLUS (includes the QIAxcel Advanced workstation, installation, QIAxcel ScreenGel software, required training sessions for the operation of the system, a computer for operation of the system, and a maintenance record of work performed upon the equipment)

· 3 QIAxcel RNA QC Kit v2.0

4. SCOPE OF WORK

The awarded vendor will provided the below items with the listed product support. These products have only one manufacturer (Qiagen).

· QIAgility HEPA/UV (PC) PrioPLUS (includes the QIAgility workstation, QIAgility software, system installation, required training sessions for operation of the system, a notebook computer for the operating system, and a maintenance record of performed upon the equipment)

· Warranty extension to 3 yrs

· On-site service, 48 hr response

· Preventive Maintenance (1 onsite pipetting head service and inspection per year)

· Priority service provision over non-contract customers

· Documented installation & PM report

· Unlimited number of repair service

· All costs covered

· QIAxcel Advanced, PrioPLUS (includes the QIAxcel Advanced workstation, installation, QIAxcel ScreenGel software, required training sessions for the operation of the system, a computer for operation of the system, and a maintenance record of work performed upon the equipment)

· Warranty extension to 3 yrs

· On-site service, 48 hr response

· Preventive Maintenance

· Priority service provision over non-contract customers

· Documented installation & PM report

· Unlimited number of repair service

· All cost covered

· 3 QIAxcel RNA QC Kit v2.0 (1200)

5. QUALIFICATIONS

Vendor must provide both an automated liquid-handling robotics system (QIAgility HEPA/UV (PC) PrioPLUS) for 96-well plate transfers and creation of archival sample plates (creation of our sample repository). The QIAgility HEPA/UV (PC) PrioPlus Package includes the QIAgility workstation, QIAgility software, system installation, required training sessions for operation of the system, a notebook computer for the operating system, and a maintenance record of performed upon the equipment. We will also purchase a 96-well format bioanalyzer (QIAxcel Advanced, PrioPLUS) for rapid, high-precision setup for the subsequent analysis of the samples to determine both the integrity and concentrations of the RNA (requirements for downstream analysis of the samples by digital PCR or transcriptomics). The QIAxcel Advanced PrioPlus Package includes the QIAxcel Advanced workstation, installation, QIAxcel ScreenGel software, required training sessions for the operation of the system, a computer for operation of the system, and a maintenance record of work performed upon the equipment. We will also purchase the necessary consumables for operation of the QIAxcel Advanced, PrioPLUS, the QIAxcel RNA QC Kit v2.0, for the analysis of the 3,000 samples detailed in our research project outline. These kits are the only kits that are compatible with the QIAxcel Advanced, PrioPLUS system. Critical steps in this project are the creation of an archival repository for the 3000 RNA samples and the automation of the reaction mix set-up steps, which will be performed in 96-well plates. It is neither logistically nor economically feasible for this to be performed manually. The QIAgility HEPA/UV (PC) PrioPLUS robotics system from Qiagen provides a high-throughput platform for this and includes a UV light for effective worktable decontamination that removes concerns regarding the potential for contamination of the samples during these processing steps. Further, a HEPA filtration system within the instrument provides positive clean air pressure throughout all of the 96-well plate processing steps including the creation of the archival repository and downstream bioanalysis and digital PCR analysis. Our investigation also requires measurements of the integrity and concentrations of the RNA samples using a bioanalyzer instrument. Current bioanalyzer technologies by other companies are largely relegated to the analysis of 10-12 RNA samples per run on the respective instruments. As our project requires the analysis of 3000 RNA samples this would again be a significant impediment both logistically and economically. The QIAxcel Advanced PrioPLUS bioanalysis instrument provides a high-throughput platform that allows for the analysis of 96 RNA samples in tandem thus removing these impediments. The outlined project also requires the extraction of RNA from 3000 whole blood samples drawn.

6. OBJECTIVES

The receipt of the below items by the CCMD.

· QIAgility HEPA/UV (PC) PrioPLUS (includes the QIAgility workstation, QIAgility software, system installation, required training sessions for operation of the system, a notebook computer for the operating system, and a maintenance record of performed upon the equipment)

· QIAxcel Advanced, PrioPLUS (includes the QIAxcel Advanced workstation, installation, QIAxcel ScreenGel software, required training sessions for the operation of the system, a computer for operation of the system, and a maintenance record of work performed upon the equipment)

· 3 QIAxcel RNA QC Kit v2.0

7. PERIOD OF PERFORMANCE

The period of performance is a single purchase of the product, which will be provided during the base year.

Base year: September 1, 2015 to August 31, 2016

8. IDs/SECURITY CLEARANCE

Contractor will need to visit the NIH Campus Clinical Center to complete work associated with the contract.

Employees hired to work under this contract will be citizens of the United States or, if aliens, have the appropriate permits to work. Employees must be fluent in the English language. It is the Contractor’s responsibility to perform past performance reference checks in order to insure a secure and safe work environment for NIH.

Parking:

Contractor will need to come to the NIH campus.

No Smoking Campus:

Effective October 1, 2008, the use of all tobacco products is prohibited on the NIH Bethesda Campus. This includes cigarettes, cigars, pipes, smokeless tobacco ("snuff"), and any other tobacco products. The use of these products in private vehicles located on the NIH Bethesda Campus is also prohibited.

9. QUALITY CONTROL AND MONITORING

Contractor performance will be monitored by Government personnel for compliance with the degree of skill, customer service, and learning expected of a reasonably prudent health care provider in a similar professional setting.

Competence/Conduct/Performance NIH reserves the right to terminate service agreement based on poor performance, inappropriate behavior or attendance issues.

10. INVOICE REQUIREMENTS

1. One invoice once the service has been completed

1. List name of contractor

1. Dates service provided

1. Exact hours worked to complete service

1. Bill Rate per Hour

1. Total for entire invoice

5. The contractor shall submit the original and a copy of the invoices concurrently as follows:

0. An original to the following designated payment office:

National Institutes of Health Office of Financial Management Commercial Accounts, Room 4B-432 2115 East Jefferson Street MSC 8500 Bethesda, Maryland 20892-8500

0. One copy to the Administrative Officer at:

National Institutes of Health Critical Care Medicine Department, Clinical Center 9000 Rockville Pike Building 10, Room 2C145 Bethesda, Maryland 20892