SOURCES SOUGHT
65 -- Nutritional Supplement/Tota; Parenteral Nutrition (TPN) and Continuous Veno-Venous Hemofiltration Solutions
- Notice Date
- 2/17/2005
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation 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, MD, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- CC-05-07
- Response Due
- 3/10/2005
- Archive Date
- 3/25/2005
- Description
- This is a Request for Information and Sources Sought Synopsis to identify possible potential sources for submission of capability statements from vendors with the capability to prepare sterile patient specific Total Parenteral Nutrition(TPN) and Continuous Veno-Venous Hemofiltration(CVVH) Solutions as further summarized herein for the Clinical Center,Pharmacy Department. The vendor will provide TPN and CVVH solutions on a daily basis, 7 days per week, and 52 weeks per year. The solutions must be delivered the same day that they are ordered. The vendor will receive the TPN/CVVH orders from us, prepare the requested solutions and deliver these solutions to us by a set time every day. Labeling of correctly prepared solutions must have a patient specific label with fields to be determined by us. Vendor will be required to address their capabilities to provide a second delivery on an emergent basis. Vendor will be required to maintain patient confidentiality throughout this process. The vendor will be required to provide necessary hardware and software to electronically send TPN/CVVH orders from the Clinical Center Pharmacy Department to the vendor?s preparation site. The software must be capable of checking for appropriate dose, osmolarity, drug/ingredient incompatibilities. The hardware and software used in the above processes will be owned and maintained by the vendor and returned to the vendor upon termination of contract. Vendor will also provide an automated compounder/software capable of preparing base solutions of TPN/CVVH to Clinical Center Pharmacy Department at no charge. This automated compounder will be used to make up base solutions of TPN/CVVH on an emergent basis. The vendor supplied automated compounder will be owned and maintained by the vendor including any software that is necessary to operate the compounder. Vendor must demonstrate compliance with USP Chapter 797, must have all applicable Pharmacy licenses required by the state of Maryland or whichever state the vendor is operating in, must be registered with the US FDA as a manufacturer and must have a valid and current controlled substance registration issued by the US DEA. All of these licenses/registrations must by current and valid throughout the entire contract period. Vendor must be able to demonstrate compliance with all JCAHO requirements and FDA regulations that apply to sterile products, good manufacturing procedures (GMP) and quality assurance. Vendor must provide a quality assurance plan that addresses sterility, accuracy, safety of product and show validation of their process. Vendor must provide access to the Clinical Center Pharmacy Department Chief or his/her designees to inspect their manufacturing facility based on USP Chapter 797, JCAHO and FDA sterile products regulations and guidelines, twice a year. The vendor should consult the specific regulations for further details, exemptions and documentation. This is not a request for proposals or quotes and in no way obligates the Government to award any contract. The North American Industrial Classification System (NAICS) Code is 325412. The purpose of this survey is to investigate the market for vendor?s capabilities for this Government requirement and allow the Government to obtain quality supplies and services at reasonable prices. Capability statements being supplied should include at a minimum the following information:1/Detailed descriptions of company experience in providing the required services, including but not limited to the following, number of years that the company has been providing the services, description of facilities where the services will be provided, how projects are managed including management controls established to ensure that work is done in accordance with contract requirements.2/Knowledge of and company experience with meeting all federal and state government regulations in health care facilities.3/ Size of company, number of employees and information deemed relevant to establish the companies capabilities to provide the required supplies and services to the government in a timely and fully compliant manner. Information provided by any vendor in response to this sources sought notice shall not be disclosed if doing so would reveal the vendors confidential information and will be protected under FAR Part 3.104. Capability statements should be received no later than March 10, 2005. Any and all proprietary and restricted information provided should be clearly marked. All capability statements should be direct to Mrs. Gail Akinbinu via e-mail at gakinbinu@cc.nih.gov or via fax at 301-496-9933. If there are any questions, the contact telephone is 301-496-0692. Please ensure that you have included your return email, address, mailing address, telephone number and facsimile number in the body of your response.
- Place of Performance
- Address: 9000 Rockville Pike Bldg 10 Room 1n249 Bethesda,MD
- Zip Code: 20892
- Country: United States
- Zip Code: 20892
- Record
- SN00753497-W 20050219/050217211721 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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