Recovery Act Contract Action - Providing radiologic outcomes for the Osteoarthritis Initiative through longitudinal, blinded to order qualitative and quantitative assessment x-ray analysis of knee joint changes

THE PURPOSE OF THIS MODIFICATION TO A PREVIOUS NOTICE IS TO REVISE THE NAICS CODE. RECOVERY ACT CONTRACT ACTION - This is a sources sought synopsis. This is not a Request for Proposals. The National Heart, Lung, and Blood Institute, on behalf of the National Institute for National Institute of Arthritis Musculoskeletal and Skin Diseases (NIAMS) issues this source sought notice in an effort to obtain information regarding the availability and capability of all qualified sources to perform this requirement. Small businesses are encouraged to respond. The period of performance is eleven months with the option to extend the contract for an additional year. The Osteoarthritis Initiative is a public-private partnership to generate research resources to increase knowledge and improve understanding of the onset and progression of knee osteoarthritis in the population. The goals of the Osteoarthritis Initiative are currently being fulfilled through five current NIH funded research and development contracts. Four of these contracts are awarded to clinical centers to enroll subjects, collect data and follow the cohort, and one contract is the data coordinating center, the University of California, San Francisco to manage the study and to establish and maintain the database. The purpose of this requirement is to provide x-ray readings and scoring of knee x-rays from the baseline, 12, 24, 36, and 48 month x-rays from the participants of the Osteoarthritis Initiative. This will provide outcome data to enrich the database. These readings will allow users to know whether subjects without disease have developed disease or subjects with disease have gotten worse. This information is critical for evaluation of potential risk factors for development or progression of disease. Providing these readings through a standardized method will eliminate the variability that would result from many different individuals reading these x-rays independently. The resultant data will be posted on the Osteoarthritis Initiative public website after review by the staff at the data coordinating center at the UCSF. Two types of readings, done in a blinded to order manner are required: quantitative assessment of joint space width and change in joint space and semi-quantitative assessment of joint changes including the Kellgren-Lawrence score. The proposed readings are not - commercial items. They are not conventional clinical readings that might be offered by a radiology department to primary care doctors for diagnosis of knee osteoarthritis. Rather, they are research readings that require the collection of a large set of predefined variables from the radiographs that are useful only in the research setting. These readings require structured protocols to maximize the accuracy and reduce sources of error. These readings are unique to research assessments due to the following requirements; assessment of a large set of individual radiographic features, which are not used clinically, readings of grouped images from multiple time points for precise measurement of change, readings of images blinded to chronological order, use of multiple readers to assess same images to increase accuracy and reduce error, identification and adjudication of discrepancies between multiple readers by outside party, precise measurement of joint space width at multiple points across the joint and precise comparisons of change in joint space width from image to image. Capabilities Statements will be evaluated based upon the following evaluation criteria: 1. Adequacy of technical approach to provide reliable readings using well established and accepted methodologies for both quantitative and semi-quantitative assessment of longitudinal x-rays from the OAI. 2. Ability to properly handle, process, store, and disburse x-rays and data. 3. Ability to work cooperatively with the Government to establish clear and well documented policies and procedures for access to x-rays/data. 4. Ability to work cooperatively with the Government to address various ethical, legal, policy, and regulatory issues related to collection, access, and distribution of x-rays including evidence that the offeror is familiar with processes and procedures relevant to shipping and receiving x-rays to and from subcontractor sites. 5. Documented training and expertise for various tasks related to the operation and maintenance and familiarity with various ethical, legal, and policy issues related to collection, access, and distribution of x-rays. 6. Leadership and management structure must include the documented training, experience, leadership, and availability of a lead Principal Investigator with solid research program management experience. It should also include documented experience in managing subcontracts and suitability of proposed plans for start-up and for orderly transition to a successor contractor or the Government. The administrative framework must indicate clear lines of authority and responsibility. These include adequacy and feasibility of the proposed staffing for the conduct of the project, including the appropriateness of the time commitments for proposed staff, the clarity and appropriateness of assigned roles, responsibilities, plans for back-up staffing as the need arises, and the logistical adequacy of the proposed staffing plan. 7. The offeror should demonstrate adequacy, availability and accessibility of existing resources such as computer equipment, computer software, web systems, data security, and office space necessary to effectively carry out all phases of the proposed project, including plans for back-up in case of equipment malfunction. This is not a request for a competitive quotation. However, if an interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must demonstrate the ability to provide the x-ray reading services and assessments as well as the facilities and staffing to perform these services, as described above. All responses must be received in writing and must contain material in sufficient detail to allow NIAMS to determine if the party can perform this requirement (responses should not exceed 20 pages including attachments). Responses providing insufficient information will not be considered. This is not a Request for Proposals (RFP), nor is an RFP available. The Government intends to solicit and negotiate with only one source, The University of California, San Francisco, under the authority of FAR 6.302-1. The University of California, San Francisco is located at 3333 California Street San Francisco, CA 94143 and is currently operating under contract number N01-AR-2-2258. The NAICS code is 541712. Statements of capability must be received at the following address (or by email as a Word document or PDF) no later than 4:00 pm local time, July 30, 2009: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II - Room 6102, 6701 Rockledge Drive - MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Lisa A. Hill, Contracting Officer, hilll1@mail.nih.gov.