SOLICITATION NOTICE
A -- The Osteoarthritis Initiative – Data Coordinating Center
- Notice Date
- 9/9/2011
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-AR-2012-15-KB
- Archive Date
- 9/3/2012
- Point of Contact
- Kelli T Broda, Phone: 301-435-0332, Kristiane E Cooper, Phone: 301-435-6674
- E-Mail Address
-
brodak@mail.nih.gov, cooperke@nhlbi.nih.gov
(brodak@mail.nih.gov, cooperke@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to solicit and negotiate on a non-competitive basis with the University of California, San Francisco (UCSF), the Data Center for the Osteoarthritis Initiative (OAI), and award a contract to complete participant follow up visits for the OAI. UCSF is located at 3333 California Street San Francisco California 94143. The cited authorities are 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1 and HHSAR 306-302-1. The anticipated period of performance is for a period of three years. The University of California, San Francisco (UCSF) was awarded a contract in 2002 on a competitive basis to perform as the Osteoarthritis Initiative Data Coordinating Center. Awarding a contract to UCSF will allow for consistency with their past history as the Data Coordinating Center for the OAI. The UCSF has established data systems for receipt of the clinical (scanned) and imaging (electronic transfer) data from the Clinical Centers, data cleaning and editing systems for quality assurance of received data with feedback for missing systems for missing or incorrect data, and the two web based systems 1) for archiving protocols and data and communication with the clinic centers and 2) for providing OAI clinical data and images to the research community. The UCSF has developed and validated all clinical and imaging protocols used in the OAI Clinical Centers and provided training and certification of personnel at these sites to carry out these measures. The UCSF has strong working relationships with the four existing clinical centers and has established unique and secure lines of communication with these centers. It is essential that there is no time lag between contracts to allow for continuous patient visits at the clinical centers. Thus, there is a need for continuous oversight and management from the existing contract to the new one. Additionally, the UCSF holds and manages public access to all the current data and images, biospecimens for the entire OAI resource. Continued management of the four clinical centers and the public database by the UCSF provides experienced oversight that results in a low risk, continuity of effort, cost effective, and efficient process. The OAI has recruited and followed 4800 subjects at high risk for osteoarthritis disease and progression. For consistency purposes, the data collected at these final visits of the OAI cohort must be done in an identical manner to those already in the dataset. This is best and most efficiently accomplished by the same experienced team. If these duties had to be performed by another organization, there would be considerable cost to the government for start-up and establishment of systems that currently exist at UCSF and unacceptable delays in fulfilling the NIAMS requirements. To capitalize and expand upon the resources of data, specimens, and infrastructure developed over the last nine years, the aims of the follow up study will include: 1. During the remaining extended follow-up (3 years), the DCC contractor will develop, implement, and oversee the following activities at the four OAI Clinical Centers: A. Mail and telephone contact for entire cohort at 84 months Interviews/questionnaires 1. Assessment of pain and function using WOMAC, KOOS, and other previously used instruments at all visits 2. Monitoring of medication and CAM use 3. Assessment of overall health outcomes 4. Collection of co-morbid conditions 5. Repeat food frequency questionnaire (modified Block) at 84 month visit only 6. Measurement of occupational exposures/activities at 60 and 84 month visits 7. Measurement of development of disability and current levels of disability at 60 month visits only 8. Measurement of anxiety, pain-related fear, coping and catastrophizing at 60 and 84 month visits 9. Assessment of willingness of participants "eligible" for total knee replacement (or other similar procedures) to undergo such surgical procedures, with a focus on racial/ethnic/socio-economic variations at all visits Outcomes adjudications 1. Verification of hospitalizations and surgeries related to knee OA (other than TKR and joint sparing surgeries) reported by all participants at all visits 2. Assessment of participant reliability by interviewer 3. Adjudication of deaths and TJR for hip and knee B. In clinic visits for entire cohort at 72 and 96 months Imaging 1. Core MRI assessments on entire cohort, except those knees with radiographic end stage OA, at 72 and 96 month visits 2. Fixed flexion knee X-rays on entire cohort at 72 and 96 month visits and x-ray of pelvis and dominant hand at 96 month visit 3. DXA for BMD of spine, tibia, and hip and body composition (only at 72) at 72 and 96 month visits Specimen collection 1. Collection of routine size blood samples for archiving at 72 month visit 2. Collection of urine at 72 month visit Interviews/questionnaires 1. Assessment of pain and function using WOMAC, KOOS, and other previously used instruments at all visits 2. Monitoring of medication use at all visits and CAM use at 96 month visit 3. Assessment of overall health outcomes at all visits 4. Collection of co-morbid conditions with adjudication, particularly focused on obesity/cardiovascular/endocrine disorders 5. Measurement of occupational exposures/activities at 96 month visit 6. Measurement of development of disability and current levels of disability at 96 month visit 7. Measurement of anxiety, pain-related fear, coping and catastrophizing at 96 month visit 8. Assessment of willingness of participants "eligible" for total knee replacement (or other similar procedures) to undergo such surgical procedures, with a focus on racial/ethnic/socio-economic variations at all visits Physical measurements 1. Weight annually and height at 96 month visit 2. Abdominal circumference at 96 month visit 3. Performance measures in entire cohort at 72 month visit (20-meter walk and timed chair stands) and in entire cohort 96 months (20-meter walk, 400-meter walk, and timed chair stands) 4. Physical assessment of mobility and disability at 72 months Outcome adjudication 1. Verification of hospitalizations and surgeries related to knee OA (other than TKR and joint sparing surgeries) reported by all participants at all visits 2. Adjudication of co-morbid conditions, particularly focused on obesity/cardiovascular/endocrine disorders at 72 and 96 month visits 2. All data and images to be maintained at OAI online and other media to allow real time access to clinical data and images for analyses. Maintain website in active state with regular updates. 3. Final Contract Closeout: Provide for sufficient, orderly, and safe transition of data systems, documents, and other contract-generated information and materials to the Government or another designated organization authorized by the Government. Specifically, the contractor shall, but is not limited to the following: a. Ensure that x-rays, MRI scans, manuals, databases and directories developed by the contractor are accurate and current, and provision is made for the orderly transfer of these materials to the Federal Government or another designated organization authorized by the Government, together with complete documentation needed to understand their content, operation and maintenance. b. Transfer all contract-developed or government-acquired publications, reprints, abstracts and other documents, results of searches, databases and necessary files to the Federal Government or another designated organization authorized by the Government. c. Transfer all Government purchased or furnished computer hardware, software and other related government equipment, including computer books or documents, and impart the knowledge of its functions to the Federal Government or another designated organization authorized by the Government. Additionally, the DCC will establish (if needed) or maintain the following: 1. Quality assurance for operation of 4 MR scanners at clinical centers 2. Methodologies for receipt of images from Clinical Centers and quality assurance for images received 3. Training and certification of all Clinical Center clinical and imaging staff members 4. Biorepository for storage, archive, and access to biospecimens 5. Laboratory for preparation and storage of and access to DNA 6. Provide travel for PI or Co-PI to attend and present at 2 national or international meetings per year 7. Organize 4 OAI Steering Committee meeting/year: one meeting should be face to face in Chicago, Il This notice of intent expires 15 days from its posting. This is not a request for proposals (RFP). The estimated award date is July 2012. All responsible sources may submit capability statements demonstrating their ability to perform this research effort on the same study participants. Any interested parties in this or potential subcontract opportunities may contact Kelli Broda at brodak@mail.nih.gov or by phone at 301-435-0332. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-AR-2012-15-KB/listing.html)
- Record
- SN02570425-W 20110911/110910000852-cf2b3e5808de6d45e2536d387cc20fbf (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |