SOLICITATION NOTICE
66 -- Licensing Fee and Upgrade Maintenance
- Notice Date
- 11/22/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 18000477
- Archive Date
- 12/7/2017
- Point of Contact
- Andre M. Moody, Phone: 3014022677
- E-Mail Address
-
moodya@cc.nih.gov
(moodya@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The Government intends to award a fixed price purchase order to BBCS Computer Systems, Pocomoke City, MD. This request is in direct support of the Donor application: Blood Bank Computer System (BBCS) used in NIH/CC/DTM. The BBCS Donor application manages Blood collection and subsequent product distribution to patients at the NIH Clinical Center. The BBCS Proprietary licensure fees, and Upgrade and maintenance for the Blood Bank Computer System. (BBCS) Program are required to maintain a level of system availability in support of patient care at the Clinical Center. Primary Services sought: Quantity: 1 each Catalog #: ---- Description: Licensing fee and upgrade & maintenance services for one (1) year. The DTM is a unique blood center which collects blood and blood components from healthy donors to treat patients participating in many protocols. Blood components are collected to support biomedical research performed in laboratories at NIH, and patients also donate blood products to determine the therapeutic benefit of removing various blood components or to obtain blood components needed to treat their medical condition. Numerous regulatory authorities, specifically the Food and Drug Administration (FDA) and American Association of Blood Bank (AABB), set policy and enforce this policy for use, monitoring and maintenance of equipment and systems that are used in support of patient care. The use of a validated IT system is standard of care for both blood collectors and transfusion services. IT systems in blood collection facilities are considered a medical device and must be FDA approved unlike all other hospital IT systems. The current version of the BBCS must be upgraded from version 5.4.3 to ABO Suite version 2.1. The upgrade is considered a mission critical to meet several AABB and FDA regulatory requirements. The requirements include the ability to defer donors by specific product type, the ability to have separate parameter evaluations for male/female iron levels, the ability to comply with the latest product labeling regulations and meet user interface requirements for standard user interface with the application. Similarly, licensure fees for DTM users must be in place as well as maintenance fees for this upgraded application. BBCS services must originate from BBCS co. Without and upgraded system, the proper licensure and maintenance, the NIH CC/DTM will not be able to provide the required support to patients at the Clinical Center as DTM will not be in compliance with the AABB and FDA regulatory requirements. If the department did not receive this upgrade and licensure fees, this would require seeking another source though there are no other known sources in the area of blood banking systems and program, reviewing that system to verify it meets the needs, a demo, validation and qualification of the system based on regulatory requirements, and retraining of the Blood Services Section staff. This would take several months to accomplish.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18000477/listing.html)
- Place of Performance
- Address: 6707 Democracy Blvd., Suite 106, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04747820-W 20171124/171122231135-343cad6dafa26fd2543df4bb54593d3c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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