SOLICITATION NOTICE
B -- Notice of Intent to Sole Source to the University of Michigan
- Notice Date
- 3/13/2014
- 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, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 14-223-SOL-00047
- Archive Date
- 4/12/2014
- Point of Contact
- Beth A. Goldberg, Phone: 3018277153
- E-Mail Address
-
beth.goldberg@fda.hhs.gov
(beth.goldberg@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration intends to award a Sole Source contract to University of Michigan Medical Center, 503 Thompson Street, Ann Arbor, MI in accordance with FAR part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The project is Abdominal Aortic Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes - AAA-CARE. The purpose of this contract is to collect the patient demographics and clinical data associated with each anatomical record that FDA has in the Characterization of Human Aortic Anatomy Project (CHAP) database so that we can perform our analysis under AAA-CARE. This research project is designed to retrospectively collect patient demographics, medical history, anatomic data, and treatment history from different clinical centers in the United States. To achieve this objective, the contractor will collect this data and enter it into an Electronic Data Capture (EDC) system for analysis by FDA. University of Michigan Medical Center (UM) is one of eleven clinical centers currently enrolled in the Characterization of Human Aortic Anatomy Project (CHAP), which is a Critical Path Project being funded by FDA's CDRH. The goal of CHAP is to collect de-identified anatomical data from patients with infrarenal abdominal aortic aneurysms. All of the clinical centers enrolled in CHAP were selected because our collaborator at that clinical site consecutively submits all of his pre-operative CT scans of his patients with abdominal aortic aneurysms to the third party core lab (M2S, Inc, Lebanon, NH) for analysis. M2S independently reviews each scan and records anatomic measurements into its database. These measurements are directly entered in the patient records and sent back to the vascular surgeon at UM. This information is then used to make important clinical decisions. The consecutive patient enrollment is crucial as it eliminates bias in the data. There are many centers that submit CT scans of their patients' anatomy to M2S for analysis. However, some clinical centers self-select cases for M2S analysis. The reason could be that the cases are challenging and that the clinical site is not equipped with tools to assess the severity of the disease. The clinical centers (and respective collaborators) enrolled in CHAP do not self-select. Therefore, we have assurance that the data gathered from those sites represent the clinically treated population, which is important for addressing our public health mission in AAA-CARE. SCOPE OF WORK CDRH/ODE requires a contractor to retrospectively collect patient demographics, medical history, treatment type, and follow-up data (per the data capture forms from the Vascular Quality Initiative (VQI) - attached) for each patient that is in the CHAP anatomical database. Patient List - In order for the contractor to begin, they will need a list of the patients to access. These patients are the ones that are in the CHAP database. In 2010, M2S provided FDA with a database of patients from UMMC. After we applied filters to the database (e.g., to remove duplicate scans), we developed a new CHAP database. The CHAP database has patient identifiers that link with M2S's complete database (also known as PEMS). The contractor will take the patient list that FDA prepares and use the patient identifiers to access the patient medical record number from the M2S PEMS database. Then, the contractor will take the medical record number that is in the M2S patient file and access the patient information from UMMC (as described above) and enter it into the EDC system through the VQI. The FDA shall provide the contractor with the list within 30 days of the award. Qualifications - UMMC will hire a person who will enter the patient data into the EDC system. The person will need the following qualifications: 1. access to hospital computers in Dr. David Williams's laboratory, 2. access to Dr. Williams's patients records in the hospital, the M2S PEMS database, and the VQI database, 3. HIPAA certification to access and review patient data, 4. medical knowledge to review and decipher patient records from Dr. Williams, 5. ability to enter the data per the VQI form into the EDC system, Data Entry - Once the person has retrieved the medical record number from the PEMS, they will use the medical record number to access the electronic patient file. The person will then use the VQI data collection form (attached) and fill in each block on the form, as the data are available in the patient medical record. If questions arise regarding the patient data, missing data, or how to enter the data in the EDC system, the person is to contact Dr. Williams or FDA's contact. Mock Entry - To ensure that the data will be collected as directed, the contractor shall perform mock data entry on paper and submit those documents to the FDA. The person collecting the data will select two patients from the patient list, find their patient record using the medical record number, enter the data from the record to the VQI form by hand, and then email or fax those forms to FDA's contact, along with a copy of the de-identified patient record. Once the FDA approves the results of the mock data entry with the VQI form, data entry into the EDC system can begin. Report - When the last patient has been entered into the EDC system, UMMC will submit a draft written report 120 after award detailing the following information: • the number of patients from the patient list that had complete medical records and were entered into the EDC; • the number of patients from the patient list that had partial data (more than 50%) and were entered into the EDC; • the number of patients from the patient list that had partial data (less than 50%) and were entered into the EDC; • the number of patients from the patient list that were not entered into the system; • the number of patients from the patient list that were treated via open surgical repair; and • the number of patients from the patient list that were treated with endovascular repair. Once FDA reviews and comments the draft report, UMMC will submit a final written report 30 days after the receipt of FDA's comments. Confidentiality - Any patient identifiers (name, social security number, address, etc.) shall not be shared with FDA. All information submitted to FDA from the EDC system will only be used by FDA and the collaborators of AAA-CARE. The only data to be shared with the FDA from the VQI are the cases identified by FDA. Period of Performance: 6 months after date of award Deliverables ACTION DELIVERABLE DELIVERY DATE Post-Award Kick-off teleconference meeting between FDA and Contractor This may be applicable -could be once person is selected - talk with them to make sure all is understood Within two (2) weeks of award. FDA provides contractor with draft materials Patient list Within thirty (30) days of award Contractor provides Mock Data Entry Mock Data Entry on two (2) patients Within forty-five (45) days of award. FDA gives comments on Mock Data Entry Comments and Approval of Mock Data Entry Within sixty (60) days of award. Post- Mock Data Entry Approval (Data Collection) Contractor enters patient data into the EDC system Electronic Data Capture for all patients on the patient list Within sixty (60) days of Approval of Mock Data Entry Post-Data Collection Contractor provides FDA with draft report. One (1) electronic copy of a brief report summarizing findings as described above in Report section Within thirty (30) days of completing data collection FDA provides contractor with comments on draft report FDA will review the draft report and provide comments Within two (2) weeks of receipt of draft report Contractor provides FDA with final report One (1) electronic copy of a brief report summarizing findings as described above in Report section Within two (2) weeks of receipt of FDA comments on draft report The NAICS code is 541712 - RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT BIOTECHNOLOGY) This notice is not a request for competitive proposals. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Part 13. Response Date: 3:00 p.m. ET March 28, 2014. Please email inquires to Beth Goldberg at beth.goldberg@fda.hhs.gov
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