SOURCES SOUGHT
70 -- Physician Office Survey
- Notice Date
- 1/13/2009
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- 1052514
- Archive Date
- 3/3/2009
- Point of Contact
- Linda Giles,, Phone: 301-827-7048, Ted Weitzman,,
- E-Mail Address
-
linda.alexander-giles@fda.hhs.gov, ted.weitzman@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of qualified small business (including certified 8(a), HUBZone, services disable veteran-owned) that can provide access to health care practitioner prescribing data. Continued access to healthcare practitioner prescribing practices data (e.g. physician survey, electronic medical records) will complement and strengthen the utility of FDA's Adverse Event Reporting System (AERS) currently in place. Access to these data also increases the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the effectiveness of product labeling in influencing prescribing behavior. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process. The contractor shall provide the following: Provide FDA personnel with real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, data on health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting using surveys and/or electronic medical records; data with the capability of providing national patterns of health care practitioner prescribing patterns in the outpatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel; data with a maximum of a 6-month lag time, i.e., time between the date of prescriber/patient encounter and date of the data availability for FDA use. Provide FDA Personnel with it direct, unlimited, Internet or network-based access to all HIPAA-compliant data in a multi-user environment and in real time. 1) Data Requirements. The successful Contractor shall have continuous access to data resources on health care practitioner prescribing practices including, but not limited to drug treatment patterns, patient demographics and indications for treatment in the outpatient setting throughout the length of the contract. The source data can be obtained from electronic medical records (EMR) or a survey of healthcare practitioner prescribing practices. FDA requires access to such data to obtain national estimates or counts. The FDA has no interest in knowing the identity of any patient, provider, or health plan included in the data. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use For survey data, the Contractor shall project the data to the national level using a FDA approved projection or other appropriate methodology. Results from projections shall be comparable to estimates obtained from national benchmarks such as the National Center for Health Statistics’ National Ambulatory Medical Care Survey (NAMCS). For EMR data, FDA understands that the data may or may not be projected. If EMR data are projected, the above applies. The data resource(s) shall have raw/sample and projected numbers throughout the length of the contract. These data resources shall be accessible via a secure Internet or network-based method permitting simultaneous, multi-user access through a user friendly data query tool(s). The health care practitioners (e.g., physicians, physician’s assistants, nurse practitioners, dentists) prescribing practices data shall include visits, and patients; characterization of individual health care practitioners in terms of number, specialty, practice setting, age, gender, geographic region and U.S. Census region. Additionally, these data shall provide health care practitioner prescribing practices data in terms of type of facility (e.g., surgi-centers, staff model HMOs, clinics), geographic region and U.S. Census region and where possible the contractor shall provide a comparison to national figures. The patient specific population data shall include the number and percent of patient populations of special interest to the FDA, including children (≤ 17 years), infants (<1 year), women of childbearing age, and elderly (≥ 65 years); the health care practitioner turnover rate for participation in data resource; and the demographic distribution of patients (age and gender required; race, if available). The patient-specific basic data elements at the visit level shall include (but are not limited to): patient demographics such as age (specify method by which age is obtained and how it is displayed in canned reports i.e. standard age groups, customized age groups, single years), gender and specify if other data elements are available which would include race/ethnicity; height and weight; clinical measures, i.e., blood pressure, cholesterol, smoking status; type of insurance; and geographic region. The drug-specific basic data elements shall include generic/trade name of drug; linkage between generic and established name; strength; dosage form; new vs. continued therapy; days supply; prescriber specialty; quantity prescribed; directions for use; indication(s) for use, and source of drug (sample provided, prescription given, product administered). The diagnosis-specific basic data element shall describe the patient’s condition as identified by the health care practitioner during the time of the office-visit; as well as visit-specific basic data elements with the time of visit (month, year); the type of visit, e.g., first vs. subsequent visit; and the type of outpatient setting and the health care practitioner-specific basic data elements shall include the type of practitioner; specialty; age; gender; and geographic region. The data resource shall include a drug coding system that consists of drug, clinical or medical coding levels for FDA data analyses; and if available, quantify the prescribing of drug- or biologic products in the outpatient setting by healthcare professionals. For examining visit-level prescribing data for products the data resource shall link clinical or medical data on indication in detail. For examining data on visits for specified disease or medical conditions, and associated treatments (if any), the data resource shall capture the drugs prescribed to treat the same diagnosis as well as all drugs mentioned during the visit regardless of diagnosis. In the event of changes to the Contractor’s business or agreements with their data suppliers, the FDA shall be notified within 5 business days of the Contractor becoming aware of such changes. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics. To protect any sensitive data which may be transmitted electronically between the data vendor and the FDA, the data vendor shall participate in the CDER secure electronic mail system. The contractor shall provide a minimum of two training sessions per year. The Contractor shall provide a support package consisting of technical, analytical, and clinical support throughout the length of the contract. In addition, the Contractor will be required to conduct an on-site annual meeting for the purposes of discussing product enhancements, contract performance, and FDA satisfaction with all deliverables. Monthly usage reports detailing use of the resource by individual FDA users and type of use (if applicable) are required. 2) Technical Requirements and Capabilities. The patient-level and/or visit-level data shall be a currently existing, commercially available, HIPAA-compliant product that shall provide immediate automated access with the capability of providing characterization of health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting. The data shall be HIPAA-compliant product that shall provide immediate automated access with the capability of providing both current and historical national-level prescribing practice information. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to software and data. Access shall be via secure Internet or network-based methods and shall be in a multi-user environment. The network-based methods shall not necessitate any additions to the FDA communications infrastructure. Access shall be through an interface and this interface shall be user-friendly, transparent and flexible enough to meet the FDA’s needs. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports. FDA requires the ability to make national estimates of visit-based and/or patient-based outpatient health care practitioner prescribing practices using projection or other appropriate methodologies, which shall be valid, reliable, and robust with regard to prescribing practices specifically, and the methods fully disclosed. The FDA shall have the ability to archive and analyze historical data in a timely manner. The FDA shall have the ability to download (or obtain in a timely manner using other means) and analyze patient level data, if available. FDA’s preference is that unrestricted access to datasets shall be available on demand and without intervention by the Contractor. The NAICS Code is 541990; size standard is $6.5M. Interested small business must provide a capability statement demonstrating their experience, skills and capability to fulfill the Government requirement that is stated above. However, be advised that generic capability statements are not sufficient to evaluate your capability statement effectively. Information submitted must be in sufficient detail to permit the government to determine whether your organization meets the government requirement. This notice is for planning purposes only, and does not constitute a Request for Quotation. This request is not to be construed as a commitment on the part of the Government to award a purchase order or contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit information via email copies of their capability statement, addressing the areas above. NO CALLS WILL BE ACCEPTED. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT VIA E-MAIL to Linda Alexander-Giles at linda.alexander-giles@fda.hhs.gov, no later than February 16, 2009 at 3:00 PM Eastern Time for consideration.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=ddf0d6a5c73200f4d3719246ce45d92e&tab=core&_cview=1)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01731815-W 20090115/090113220110-ddf0d6a5c73200f4d3719246ce45d92e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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