SOURCES SOUGHT
B -- Collect Data on Supply of Plasma Derivatives & Their Recumbinant Analogs
- Notice Date
- 4/30/2002
- Notice Type
- Sources Sought
- 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
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-02T169200
- Response Due
- 5/14/2002
- Archive Date
- 5/29/2002
- Point of Contact
- Nickie McKenna, Contract Specialist, Phone 301-443-7078, Fax 301-443-2761, - Nickie McKenna, Contract Specialist, Phone 301-443-7078, Fax 301-443-2761,
- E-Mail Address
-
nmckenna@psc.gov, nmckenna@psc.gov
- Description
- The Office of Public Health and Science (OPHS) through the Program Support Center (PSC), is seeking sources to collect data on the supply of plasma derivatives and their recombinant analogs. The purpose of the requirement is to extend monitoring by DHHS of inventory and consumption to the consumer end of the plasma derivative chain with an anticipated end result of providing: (1) both producers and consumers of plasma derivatives with information which will be useful in anticipating and preventing product shortages; and (2) post marketing surveillance for the occurrence of adverse events associated with the use and the overuse/underuse of these products. The contractor shall collect (from plasma product reporting contractors) the amount (in milligrams or units) an individual subject infuses per day, the amount per day prescribed by a physician, the amount of product in a subject?s possession, and a list of up to ten predetermined symptoms. The contractor shall provide a secure system wherein data collection will occur via a secure website which conforms to all requirements of 21 CFR Part 11. Designated personnel at three data collection sites will use multi-tiered authentication to log onto the secure plasma website and input data into the data intake form. Data shall be entered directly into a central server. No data shall be stored on a local computer and no data shall be transferred without being fully encrypted. All data shall be stored in a secured database with a second authentication required if access to administration functions is required. The appointed Project Officer will define the project rules (tiered edit checks) which the contractor shall apply to the data intake forms to enforce appropriate data entry at the site. The system shall provide immediate feed-back to the user allowing immediate identification and correction of common data entry errors. The Project Officer shall have the ability to view the data collection in real time. As data is submitted, the Project Officer shall be able to review and query any inconsistencies, receive clarification and correct problems if required, all within the security of the system. The contractor shall provide a secure website and shall use a security methodology starting at the operating system level, the data base level and at the application level. The system shall use a User ID, Password and role codes that meet FDA Standards. The contractor shall provide a secure socket layer (SSL) protocol to encrypt 100% of the information passing over any network with 128 bit encryption which shall provide ?door to door? security and confidentiality. No data shall be stored on any local computer in order to assure maximum confidentiality, security and long-term system reliability. The contractor shall supply state of the art cluster technology for all application processing and data storage. All processing and data storage shall be fully redundant with no single point of failure. The system shall automatically switch to alternate hardware and software in the event of failure of any component in the cluster allowing data collection at the sites to proceed without interruption. The cluster architecture shall facilitate regular data back-ups to the contractor?s operations center which may be remotely located from the central server cluster. In the event of failure of any sub-component, the contractor shall provide automated failure detection. Service technicians shall be available to respond within hours to replace failed components and restore full system redundancy. The contractor shall provide two (2) days of training for OPHS staff at a site to be stipulated by OPHS. Eight (8) hours of on-line support shall be available for each data collection site. The contractor shall provide 30 days of Help Desk support for staff of OPHS, as well as staff of each data collection site. Ongoing support shall consist of Help Desk support at the rate of five incidents per month. OPHS staff shall be the first line of support to the data collection sites and the contractor shall be the second line of support. Additional support shall be made available if required. The contractor shall provide round-the-clock system availability for the duration of the contract and which shall be available in an inactive state for 30 days after the contract expires so that data may be removed from the system. The AT&T International IP backbone the secure web site uses shall be available 99.9% of the time the contract is in effect. The contractor shall provide a one-hour response time by telephone. The contractor shall provide the J-Review data analysis module. The anticipated period of performance is a twelve(12) month Basic period and four (4) twelve (12) month Option periods. The closing date for capability statements is May 14, 2002. Interested concerns may identify their interest and submit a capability statement which demonstrates the ability to provide the specified services by the closing date, referencing 02T169200, Attn: Nickie McKenna, Contract Specialist. This notice is not a request for competitive proposals. No solicitation document is available at this time; therefore, requests for such document will be considered invalid responses.
- Place of Performance
- Address: 200 Independence Avenue, SW, Washington, DC 20201
- Record
- SN00068703-W 20020502/020430213158 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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