SOURCES SOUGHT
66 -- Maintenance support services for blood separtor system
- Notice Date
- 6/21/2018
- Notice Type
- Sources Sought
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- 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
- 18-012345
- Archive Date
- 6/29/2018
- Point of Contact
- Priscilla S. Abalos, Phone: 3015943879
- E-Mail Address
-
priscilla.abalos@nih.gov
(priscilla.abalos@nih.gov)
- Small Business Set-Aside
- Emerging Small Business
- Description
- Solicitation # HHSN-NIH-CCOPC-SBSS-18-01345 This is a Small business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources:(2) whether there are small businesses, HUBZONE small businesses, service disabled veteran-owned small businesses or (8a) small businesses, veteran- owned small business, woman-owned small businesses or small disadvantaged businesses veteran owned small businesses; woman owned businesses, or small disadvantaged businesses and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable code should not submit a response to this notice. Background Information The National Institutes of Health (NIH) is the nation's foremost federally funded biomedical research institution. It is comprised of twenty-seven Institutes and Centers. The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings. The NIH CC is an 870,000 square-foot facility with the capacity to serve 240 inpatient beds and 82 day-hospital stations. The Cell Processing Section (CPS), Department of Transfusion Medicine, NIH CC is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CPS operates a core facility (Charles S. Carter Cellular Therapy Laboratory) for the manufacture, storage, and distribution of cellular therapy products. CPS manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. I. Objective AMICUS Cell Separator The subject contract shall cover maintenance, support, and emergency servicing for the 6 Cell separators located in the Blood Services Section of the Department of Transfusion of the Clinical Center at NIH. The Preventive maintenance (PM) is required to comply with FDA Guidance and AABB Standards. The Cell separators are used in the collections of mononuclear cells for research, and research collections for patient's undergoing protocols- which support our mission of providing high-quality patient care, and hospital services in support of NIH Clinical research programs. Included in this contract will be a one regular preventive maintenance visit, emergency servicing, spare /replacement parts, and support for each device. Scope of work Independently, and not as an agent of the government, the contractor shall provide all necessary personnel, supplies, and services to perform the work required by this contract as set forth in the sections. The contractor shall preform the following: Preventive Maintenance (PM) The contractor shall provide scheduled preventive maintenance once every 12 months. The PM's will be scheduled by a qualified service representative + or - 30 days from scheduled due date. Services will be performed on the following: 1. Pump roller lubrication. 2. Instrument calibration: Test or inspection as indicated on Amicus Separator Field Repair Test Matrix Checklist, Document FRM-1571268980 Rev D. 3. Battery test. 4. Adjust or repair any item that does not meet manufacture's qualification criteria. Provide documentation of all work to DTM. Emergency Service Emergency service visits and repair services to include labor and all replacement parts (except disposables) for the equipment as required, except for any service or replacement parts which COMPANY determines are required as a result of the CUSTOMER'S failure to use the equipment in accordance with the COMPANY'S Operator's Manual. All maintenance will be performed in accordance with established procedures, as outlined in the current revision of the associated Service Manual. Parts /Supplies The contractor shall supply all parts and supplies needed for service and maintenance. Labor and Travel The contractor shall provide all labor and travel at no additional cost for the duration of the contract. Emergency Visits The contractor shall provide full service coverage and telephone support to correct all equipment malfunctions. The contractor shall respond within 1 hour. The on-site response for emergency should be within 24 hours. Service Calls Request for service has no designated individuals. Any employee assigned to a specific work area, can report a malfunction to one of the devices by calling the 800 number. Contract Duration: July 1, 2018 thru June 30, 2019 with base plus 2 option year. Capability Statement is to include: Information regarding respondents; (a), including their availability, experience and informal and other training; (b) current in-house capability to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts; references, and other related information: • Respondents, DUNS number, organization name, address, point of contract, and size and type of business (e.g.8(a), HUBZone, etc) pursuant to the applicable NAICS code; • Respondents; technical and administrative points of contract including names, titles addresses, telephone and fax numbers and email addresses; • Respondents must respond to this notice by June 25, 2018 at 12:00 pm Est DISCLAIMER AND IMPORTANT NOTICES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, a pre-solicitation synopsis and solicitation maybe published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a future solicitation. Primary Point of Contact Priscilla Abalos Contract Specialist Phone Number 301/594/5918
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-012345/listing.html)
- Place of Performance
- Address: National Institute of Health, 9000 Rockvile Pike, bldg. 10-1C7-11, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04963520-W 20180623/180621231145-90e2fe243008c6724605c3077ee42e02 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |