SOLICITATION NOTICE
A -- Detection and Analysis of Adverse Events related to Regulated Products in Automated Healthcare Data: Efforts to Develop the Sentinel Initiative
- Notice Date
- 5/15/2009
- Notice Type
- Presolicitation
- 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
- FDA-SOL-09-1056109
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The FDA intends to issue a Request for Quotations (RFQ) for Detection and Analysis of Adverse Events related to Regulated Products in Automated Healthcare Data: Efforts to Develop the Sentinel Initiative. The Sentinel Initiative is a response to various calls for developing active surveillance of product safety from the Agency. In September 2005, the HHS Secretary asked the Agency to expand its current system for monitoring medical product performance and to explore the possibility of working with multiple automated healthcare data systems to augment the Agency’s current capabilities of identifying and evaluating product safety information. The Secretary recommended that the Agency explore creating a public-private collaboration as a framework for such an effort, leveraging large, automated healthcare databases. In May 2008, the Secretary of Health and Human Services and the FDA Commissioner announced the Sentinel Initiative. The Sentinel Initiative is a long-term effort by the Agency to create a national electronic system for monitoring product safety. The system is intended to augment the Agency’s existing postmarket (primarily passive) safety surveillance systems and enable the Agency to actively gather information about the post market safety and performance of its regulated products. As currently envisioned, the Sentinel will enable the Agency to capitalize on the capabilities of multiple, existing automated healthcare data systems (e.g. electronic health record systems, administrative claims databases, registries) to augment the Agency’s current surveillance capabilities. Sentinel will enable queries of disparate data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be included. Questions would be sent to appropriate, participating data holders, who in turn would evaluate their data according to existing privacy and security safeguards, and send summary results for Agency review. The objective of this requirement is to provide the necessary support to facilitate the development of Sentinel and carry out mandates delineated in the FDA Amendments Act of 2007 (FDAAA), including, but not limited to, requirements in Section 905. This will be carried out via the development of specific tasks, as deemed necessary by the Agency, and outlined below in the Scope of Work. Scope of Work: a. The Offeror shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things, necessary for or incident to the performance of the work as described below. b. The scope of this requirement covers all aspects of access to automated healthcare data system(s) for active medical product surveillance; signal detection, signal strengthening, and signal validation methodologies; evaluation of scientific methods; risk communication tools; and other requirements for conducting the specified task orders. c. The Offeror shall specify the methods it will employ in accomplishing the key components of each task order. The Offeror shall demonstrate the ability to do all of the following: 1)Provide technical expertise in pharmacoepidemiology and biostatistics for identifying, developing, validating, enhancing, and implementing advanced analytical and statistical methods (related to signal detection, signal strengthening, and signal validation) to address the specific issues, challenges, and objectives outlined for each task. 2)Access (directly) and utilize data from disparate automated healthcare data systems, including, but not limited to electronic health record systems, administrative claims databases, and registries, primarily for active medical product surveillance. Demonstrate experience with methods for detecting, evaluating, and validating signals in these data. Additionally, they should have ready access/relationships with other organizations with automated healthcare data, and with the researchers that are intimately familiar with those data, whether or not they have been used for signal detection, signal strengthening, or signal validation before. a. The Offeror shall have continuous direct access to various regularly updated automated healthcare data sources containing patient-level health encounter data from the United States in a platform that protects the integrity of patient records. The data sources shall be a computerized system able to link each patient to all relevant medical care data including enrollment status, medical product exposure data, and coded medical procedures and outcomes. The data sources should include, to the extent possible, a broad range of patient populations with regard to demographics and socioeconomic status. Linkage of this data source to additional information, including vital records, chronic disease and/or cancer registries, birth defect registries, and medical device registries, if available, is also desirable. b. The data sources shall be sufficient to meet the Agency’s need to access patient-level data describing health encounters and medical product use by individuals over time. The data sources shall have longitudinal data that shall be capable of following uniquely identifiable individuals over time. c. Demographic information (e.g. age and gender), health history, diagnoses and procedures, and hospitalizations shall be available. Information on race/ethnicity shall be included where available, accompanied by documentation of the origin of this information. d. In addition, for each patient these data shall contain prescription drug and biologic utilization information, typically including but not limited to the generic and brand name of the product, manufacturer, strength, dosage form, days supply, all dates dispensed, initial/continuing therapy indicator, quantity dispensed, instructions for use, indication for use and prescriber specialty. The resources shall employ the use of a generally accepted, granular coding system for drugs and medical products, as well as for diagnoses and procedures. In addition, the Offeror shall have the ability to determine that the product was dispensed to the patient, rather than just prescribed to the patient. e. Optimally, medical device utilization by patients would also be captured, either at the device type level (e.g., by using diagnostic or procedural coding) or manufacturer level (e.g., by using registry data or bar code data). f. Although accessible databases will often not have this information, it optimally will be useful to also capture specific product identification data in addition to brand and generic name, including: lot number (and model designation for devices); product integrity (e.g. visible damage to product or container closure); expiration date; whether a sterile product; and, whether a new molecular entity. To evaluate potential interactions, data should additionally be captured when available on over the counter medications, dietary supplements and special diets. g. All patient medical diagnostic information shall be represented in the data sources, including diagnoses and procedures associated with all ambulatory, emergency, chronic or acute care setting visits and their dates, diagnoses and procedures associated with related hospitalizations and their dates, and laboratory tests and results (if available) and their dates. Other health measures (such as family health history, height, weight, body mass index, smoking status, alcohol use, blood pressure measurements, etc.), are of interest if available, as are results of imaging studies. h. The Offeror shall have the capability of accessing inpatient medical records for validating coded diagnostic data; access to outpatient medical records is also of interest if available. Patient identifiers would stay behind the firewalls of each data holder and only aggregate information would be shared with the Agency. i. The Offeror shall be responsible for ensuring that the uses of the data are HIPAA-compliant. The Agency will require no patient-, provider-, or health plan-specific identifiers and any aggregated results provided to the Agency will be provided in a standard format. All activities performed by the Offeror shall and must comply with standards for privacy of individually identifiable health information and protect the rights of human subjects in research. All analysis of data shall be performed by the data holders in their secure environment without transfer of patient level data. If FDA deems it necessary to review certain data to protect the public, data holders shall make those data available in compliance with HIPAA for FDA review. j. All data accessed should be available in a timely fashion so as to be conducive to surveillance. k. All data accessed should be from privately held, non-federal data sources from US patients. 3)Develop data identification and access plans that includes the kinds, and availability of, data necessary to complete the specified analytic task and related evaluation. 4)Develop surveillance plans and study designs, applying pharmacoepidemiological and biostatistical principles and methods. 5)Test data model options and the effects on signal detection, signal strengthening, and signal validation. 6)Provide demonstrated expertise in implementing standardized data elements in disparate automated healthcare data systems. 7) Develop and propose a secure communication strategy to support the above analysis and data access needs. If an IT architecture solution is proposed, the design shall incorporate appropriate privacy, security, and auditing mechanisms. It would not be intended to interact with any existing Agency IT infrastructure. This secure communication strategy would enable the dissemination of queries and subsequent reporting of results between accessed data sources and authorized users. The Office of Information Management/ FDA should be informed and consulted on required infrastructure components needed for the long-term support of this work. 8)Provide regular briefings to the Agency on deliverables and findings, e.g., following proposed approaches to analysis, the findings of conducted analyses, and other tasks, to obtain agency input. This could include training, as appropriate, on methods and tools employed in carrying out identified tasks. d. Examples of tasks of interest that might be awarded under this requirement would include but not be limited to: 1)Develop, apply and/or evaluate advanced statistical approaches to safety signal detection, signal strengthening, and signal validation in automated healthcare data sources for regulated products during the postmarketing period. 2)Test data model characteristics pertinent to postmarket safety analysis of automated healthcare data. 3)Create a secure communication strategy to enable coordination of disparate sources to answer questions related to active medical product surveillance. The anticipated award type is an IDIQ (Indefinite Delivery Indefinite Quantity) with time and materials for a base year and four option years. This will be a full and open competition solicitation. This contract will be awarded on best value. The designated North American Industry Classification System (NAICS) code is 541690-Other Scientific and Technical Consulting Services. All vendors must be registered in the Central Contractor Registry (CCR) prior to award of a federal contract. The website is http://www.ccr.gov. This announcement is not a RFQ. Interested parties shall submit an email to request the solicitation at Tara.Hobson@fda.hhs.gov. The solicitation will be available on or about June 01, 2009. Questions regarding this solicitation shall be received by email no later than 4:30pm EST on June 19, 2009.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-09-1056109/listing.html)
- Place of Performance
- Address: United States
- Record
- SN01819651-W 20090517/090516161311-a228f90a1eb67d2b7fd803434838a839 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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