SOLICITATION NOTICE
B -- Professional services contract for a medical expert
- Notice Date
- 6/13/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, Parklawn Building Room 5-101 5600 Fishers Lane, Rockville, MD, 20857, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-RFP07T677012
- Response Due
- 6/29/2007
- Archive Date
- 7/14/2007
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for a fixed price contract - commercial items prepared in accordance with FAR 12.6 using Simplified Acquisition Procedures under the test program for commercial items found at FAR 13.5, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested. No other solicitation will be issued. This solicitation identified as RFP 07T677012 includes all applicable provisions and clauses in effect through FAR FAC 2005-16 (March 2007). The North American Industry Classification Code is 541690. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. This is a total small business set-aside. Background For the past eight years, DIO has utilized a physician/scientist to act as its medical expert. Approximately one third of the accessions, inquiries and investigations that are reviewed by DIO involve some aspect of clinical medicine, and the physician/investigator, who will serve as a consultant, is expected to provide advice and assistance to other DIO staff as needed and to provide oversight review on a substantial portfolio of cases. This requires a wide variety of skills including but not limited to reviewing the institution reports sent to DIO for completeness, asking institutions for additional evidence or analyses as needed, and preparing written reports summarizing the DIO oversight review. These reports must be written so that the language and logic of the medical/scientific findings is clear to both other scientists and to ORI=s attorneys, who must use these reports to prepare voluntary agreements and/or charge letters to attempt to persuade respondents and their attorneys of the merits of ORI=s arguments and findings. Contractor qualifications The contractor must have an M.D. degree and a license to practice medicine. A Ph.D. in the physical sciences and substantial experience directing and conducting a research program is highly desirable. Preference will be given to contractors with experience in peer review of grant applications and manuscripts submitted to journals, and extensive publications that demonstrate writing ability and being able to communicate well with non-scientists. TASKS: 1. Provide expertise in describing for ORI the nature of the diseases and normal medical condition, the types of records that should exist, and an analysis of discrepancies in these records, from a viewpoint that recognizes their medical and scientific significance. In performing this role, the contractor will write draft and final investigational summary reports for clinical cases involving proposed ORI findings of research misconduct and provide advice for the ORI and the Office of General Counsel on such cases under negotiation for voluntary agreements. The contractor will also provide oversight review of clinical cases and accessions that do not lead to ORI findings of research misconduct. The contractor will also attend and participate in weekly meetings of the ORI Case Evaluation Council, providing comments based on the contractor=s expertise in other pending ORI cases. 2. Contractor will also provide expert advice in oversight review of accessions, inquiries and investigations requiring expertise in human and vertebrate physiology, bioengineering, and statistics. 3. Contractor will conduct historical analyses of ORI=s clinical cases and provide summaries of trends in how the inappropriate behavior of respondents in clinical cases (doctors, nurses, CRAs, etc.) changes over time. 4. Contractor shall prepare and give presentations for ORI sponsored meetings and other national and international meetings with a focus on human medicine as required, and prepare manuscripts for publication on clinical topics as they relate to research misconduct and scientific ethics. The period of performance is not to exceed 1 year (12 months) with an estimated level of 1,000 hours. Deliverables 1) written proposals for voluntary agreements, with analysis of the clinical significance, for proposed ORI findings of research misconduct in clinical cases (at least 5), and written investigational summary reports or closeout memoranda on specific cases or accessions involving clinical research that do not lead to ORI findings of research misconduct (at least 2). Attendance and participation at the weekly ORI Case Evaluation Council meetings will be recorded. Due: by agreement with the project officer. 2) written proposals for voluntary agreements, with analysis of the scientific significance, for proposed ORI findings of research misconduct in cases involving human or vertebrate physiology, bioengineering, and/or statistics (at least 2), and written investigational summary reports or closeout memoranda on specific cases or accessions involving such research that do not lead to ORI findings of research misconduct (at least 2). Attendance and participation at the weekly ORI Case Evaluation Council meetings will be recorded Due: by agreement with the project officer. 3) Data base, with report generator, on all ORI cases involving clinical research, developed during the period of this contract Due: by agreement with the project officer. 4) Draft presentations in PowerPoint and/or manuscript for publication, at least one during the period of the contract. Due: by agreement with the project officer. Partial Payments The Government anticipates making partial payments under this contract. Partial payments will be made upon Project Officer acceptance of the deliverables identified above. All invoices shall be submitted to the Project Officer for approval. Technical Evaluation Criteria The technical proposal will be scored against the evaluation criterial identified below. Each factor is weighted as shown, with a total possible score of 100. 1. Technical Understanding and Approach 30 points Demonstrate broad knowledge of medical treatment and current trends in medical research, including how to audit and interpret clinical trials, detect discrepancies in clinical records, and evaluate the significance of such discrepancies. Contractor shall also be generally familiar with research in areas of biological research such as immunology, molecular biology, and microbiology. Critical analytical skills include being able to understand and interpret medical and research records, assess reports in these areas that are sent to the Division of Investigative Oversight for oversight review, and to objectively evaluate and summarize these reports so that they can be understood by non-scientists such as lawyers and judges. 2. Personnel Qualifications 25 points Contractor shall provide a resume or resumes of the personnel intended to be used for these services in order to demonstrate that the contractor has the necessary experience, expertise, and ability to deliver the required level of service. 3. Organizational Experience 20 points Provide a description of the contractor=s experience and expertise in reviewing and assessing large and factually complex reports dealing with medical or scientific disputes. Document contractor=s experience and expertise in working with government regulatory agencies and describe the contractor=s experience in dealing with confidential records. Provide a description of the contractor=s experience in evaluating scientific grant applications to government and non-government funding agencies. 4. Management Approach 25 points Describe contractor=s approach and plan for accomplishing the objectives of the proposed work, the analytical tools to be brought to bear, and the techniques to be employed to ensure objective, timely, and high quality work. Describe the type and extent of managerial experience that the contractor has that is pertinent to the proposed work. QUESTION DEADLINE:. All questions due by WEDNESDAY, JUNE 20, BY 4:00PM and must be submitted in writing to BJMILLER@PSC.GOV QUOTATIONS ARE DUE: by email, to BJMILLER@PSC.GOV, by FRIDAY, JUNE 29TH BY 2:00PM. AWARD DATE: ? PLEASE NOTE: In order to receive an award, contractor must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun and Bradstreet number and banking information. PROVISIONS AND CLAUSES: The contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this acquisition. Full text of clauses and provisions are available at Federal Acquisition Regulation (FAR): http://www.arnet.gov/far/. OFFERORS: Offers must be submitted on a SF-1449 with separate Technical and Cost Proposals, and a completed 52.213-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror. The government will not pay for costs incurred in the preparation and submission of data or other costs incurred in the response to this announcement. No faxes will be accepted. Please refer to solicitation number RFP 07T677012 in all correspondence. The following FAR clauses apply to this combined synopsis/solicitation and can be found at http://www.arnet.gov/far/loadmainre.html 52.212-1 Instructions to Offers-Commercial Items, 52.212-2 Evaluation Commercial Items, 52.212-3 Offeror Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items. The following HHSAR Clauses also apply and can be found at http://farsite.hill.af.mil/VFHHSAR1.htm 352.224-70 Confidentiality of information, 352.270-5 Key personnel. HSPD-12 shall also apply and can be found in Attachment 1.
- Place of Performance
- Address: 1101 Wootton Parkway, Rockville, MD 20852
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01317536-W 20070615/070613220654 (fbodaily.com)
- Source
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