SOLICITATION NOTICE
B -- Evalulation and Administration Claims Data to Study Performance of Total and Partia Hip Replacement Differentiated by Bering Surface for the FDA
- Notice Date
- 9/1/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- FDA1077939
- Archive Date
- 9/24/2010
- Point of Contact
- Mary Rose A. Nicol, Phone: 3018277183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-30. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation, NAICS code 541690, is to notify contractors that the government intends to issue a Firm Fixed Price Contract in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This action is designated Unrestricted/Full and Open. The period of performance is 12 months from the date of contract award. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a Request for Quotes (RFQ). The Food and Drug Administration (FDA) intends to award a contract to study Performlnce of total and partial hip replacements differentiated by bearing surfaces. The statement of work is as follows: Statement of Work Evaluation of Administrative Claims Data to Study Performance of Total and Partial Hip Replacements Differentiated by Bearing Surface 1. Purpose The goal of the contract is to establish a cohort of patients within the Centers for Medicare and Medicaid Services (CMS) Administrative Claims Data who have received a total or partial hip replacement and to evaluate performance associated with each bearing surface. 2. Background Administrative medical claims data have gained an increased importance in the postmarket surveillance of medical devices because they contain rich information that can augment other postmarket tools used to study performance of medical devices in the real- world setting. 3. Statement of Work A) Objectives: The objective of this study is to utilize CMS data for evaluation of performance of different bearing surfaces for use in total and partial hip replacements as part of an ongoing evidence synthesis for all hip replacements. The Agency is seeking to work collaboratively with an outside entity in establishment of an algorithm to define a cohort of patients within the data who have received hip replacements as well as to create protocols for collection of short-term and long-term safety and effectiveness endpoints from the data. The Agency and contractor will work together to evaluate the cohort and endpoint data to determine rates of surgical revision and other adverse events. B) Scope of Work: 1. Identification and description of cohort of people within CMS data with a hip replacement. This should include number of patients with new hip replacement surgery by type of bearing surface using ICD-9-CM, CPT, and HCPCS codes over a specified timeframe. Cohort description should include demographic characteristics, surgical procedure information, changes in number and type of hip replacement surgery over calendar time, and hospital location and size. 2. Development of a strategy to identify and describe revisions and other adverse events of interest. Description of each type of adverse event should include demographic characteristics of patients experiencing the event, changes in number of events over calendar time, and length of time between implant and event. 3. Estimation of overall incidence rates of revision and other adverse event rates. Assess both a single, aggregate adverse event rate and changing rates across duration of implantation for each type of adverse event. Estimate both unadjusted rates and rates stratified by age, gender, and rheumatoid arthritis status. 4. Estimation of incidence rates of revision and other adverse events for each bearing surface. Assess both an aggregate adverse event rate and changing rates across duration of implantation for each type of adverse event. Estimate both unadjusted rates and rates stratified by age, gender, and rheumatoid arthritis status. 5. Comparison of the incidence rates and proportions of each adverse event related different bearing surfaces. Compare differences and ratios for both aggregate and changing rates for each type of adverse event. Estimate both unadjusted effect measures and those adjusted for known risk factors. Utilize statistical methods which account for characteristics of all variables: device implant exposure, adverse events, risk factors, confounders, modifiers, and instruments. 6. Comparison of short-term and long-term effectiveness and safety related to different bearing surfaces. Compare differences and ratios for both aggregate and changing rates for the overall number of revisions and other adverse events. Include analyses that account for only the first event experienced by each patient and for all events experienced by patients within a specified timeframe since implant. Estimate both unadjusted effect measures and those adjusted for known risk factors (as identified in the literature review which is underway). Utilize statistical methods which account for characteristics of all variables: device implant exposure, adverse events, risk factors, confounders, modifiers, and instruments. 7. Publication of findings in the peer reviewed literature. 4. Period of Performance The contract performance period will be 12 months from the date of contract execution 5. Payment Schedule Quarterly invoices will be submitted for completed work detailing work hours spend and services completed during the past month. Upon approval of each quarterly invoice, payment should be provided for services completed from 30 days of approved submission. 6. Deliverables The contractor shall: 1. Brief bi-weekly (every other week) discussions regarding progress. 2. Semi-annual report describing the work and the results. 3. Final report summarizing the work completed. 7. Evaluation Criteria 7.1. Quote Format The cover letter shall include: FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541690; delivery date (delivery date is of the utmost importance); business size; and payment terms. 7.2. Technical Proposal The Offeror shall address the following factors listed in descending order of importance. Sub-criteria under any particular evaluation criterion shall be weighted as specified below. The evaluation factors are as follows: a. Technical Approach (50%) b. Understanding the Requirement (20%) c. Key Personnel (20%) d. Relevant Experience (10%) 7.3. Technical Approach - Subfactors are of equal weight The Offeror shall demonstrate by explanation a general, but thorough, understanding of the tasks within the SOW for the development of infrastructure 7.3.1. The Offeror shall demonstrate that they have the resources necessary to manage perform tasks under scope of work 7.3.2. The Offeror shall have technical/clinical expertise to conduct the analysis and interpretations of the data 7.3.3. The Offeror shall have personnel in place to perform the needed tasks. 7.3.4. The Offeror shall have a mechanism for making periodic progress evaluations of the project. 7.4. Understanding the Requirement 7.4.1. The Offeror's quote shall demonstrate by explanation a through understanding of the requirement, in terms of: 7.4.1.1. Technical, Analytical, Clinical Services 7.4.1.2. Documentation Services 7.4.1.3. Communication Services 7.4.1.4. Program management services 7.4.1.5. Staffing Plan 7.5. Key Personnel- subfactors are of equal weight 7.5.1. The Offeror shall include a Staffing Plan for the performance of work, including roles and responsibilities of Key personnel in the overall management of the contract. 7.5.2. The Offeror shall submit resumes for personnel who may be utilized during this contract period. Resumes shall be limited to two pages. If subcontractors are proposed, resumes shall be provided for any Key Personnel positions. 7.5.3. The Offeror shall identify the name(s) of major subcontractor(s), the type of contract anticipated, an explanation of the subcontract effort, the degree of competition obtained, basis for the selection of each subcontractor, and the rationale for determining that the proposed prices are reasonable and realistic for the anticipated subcontract effort if subcontracting possibilities exist. 7.5.4. The Contractor shall provide Key Personnel with documented experience in their resumes for the responsibilities as described in the matrix below. 7.5.5. It is important that the Offeror, in performing the tasks under this award, including, but not limited to administrative and financial oversight of activities therein, not have any fiducial responsibility in an organization or entity regulated under the Food, Drug, and Cosmetics act and its amendments 7.5.6. The Offeror must have capabilities for developing and managing broad scientific programs among multiple stakeholders 7.6. Relevant Experience 7.6.1. The Offeror shall demonstrate by explanation that the key personnel are experienced and knowledgeable of and has documented experience using large administrative billing data involving implantable orthopedic implants. 7.6.2. The Offeror shall identify up to three (3) of the most relevant scientific research projects or contracts related to research of orthopedic devices involving large administrative billing data. For each relevant contract, the Offeror shall list the following: contract name, description of relevant experience, period of performance, place of performance, project contact name and telephone number. 7.6.3. The Offeror shall demonstrate by documenting experience in the field of epidemiology research. 7.6.4. The Offeror shall demonstrate by explanation the ability to organize and manage resources and personnel effectively. 7.6.5. By relevant experience, the government means the Offeror's experience that is directly related to the requirements as outlined in this statement of work. The Government intends to evaluate proposals and, if necessary conduct discussions with all responsible offerors within the competitive range. The award will be made to the offeror whose proposal conforms to the terms and conditions of the solicitation and award may be made to other than the lowest priced. Relative importance and trade-offs. The Government will base the determination of best value on performance and evaluation factors as identified above. CCR: Vendors 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 & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email maryrose.nicol@fda.hhs.gov no later than September 9 2010 at 2:00 pm ET. QUOTATIONS DUE: All quotations are due, via email to: maryrose.nicol@fda.hhs.gov, no later than 2:00 pm, EST on September 9, 2010 at 2:00 PM PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33, FAR 52.217-9 Option to Extend the Term of the Contract. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to maryrose.nicol@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1077939/listing.html)
- Place of Performance
- Address: Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN02263819-W 20100903/100901235417-020367b04209083e8aaf439718e12a13 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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