SOURCES SOUGHT
H -- Laboratory Testing Services
- Notice Date
- 10/4/2016
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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
- 17-000147
- Archive Date
- 10/17/2016
- 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 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 they are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small 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 responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Purpose for this Requirement The subject contract shall cover testing, reporting, support, and certification for non-viable particulate testing in cGMP clean rooms located in the Cell Processing Section of the Department of Transfusion Medicine of the clinical Center at NIH. The non-viable testing is required to comply with FDA 21 CFR part 11 and ISO 14644-1 and 14644-2 Standard. The non-viable testing verify that the cleanroom is operating within the required classifications. It is used to certify the cleanrooms per ISO 14644. It is also used to evaluate the effectiveness of microbial controls used in the manufacture of sterile products. It helps identify problems in the facility or process. It also help demonstrate the state of control of the aseptic processing area. STATEMENT OF WORK Introduction The National Institutes of Health (NIH) is the 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 200 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 for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase 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) 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 The NIH protocols are institutional review board approved and in the case of 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 II. Scope The subject contract shall cover testing, reporting, support, and certification for non-viable particulate testing in cGMP clean rooms located in the Cell Processing Section of the Department of Transfusion Medicine of the Clinical Center at NIH. The non-viable testing is required to comply with FDA 21 CFR part 11 and ISO 14644-1 and 14644-2 Standard. The non-viable testing verify the is operating within the required classifications. It is used to certify the cleanrooms per ISO 14644. It is also used to evaluate the effectiveness of microbial controls used in the manufacture of sterile products. It helps identify problems in the facility or process. It also help demonstrate the of control of the aseptic processing area. Work to be performed 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. IV. The contractor shall perform the following: The contractor shall provide scheduled service for non-viable testing. The service will be scheduled by a qualified representative and 30 days in advance of the scheduled due date. Services and Certifications for total of 300 sites (counts) - Perform non-viable particle count dynamic and/or static testing in (22) ISO 7 rooms and (6) ISO 8 rooms in the GMP space per ISO 14644 standard based on particles size of Perform non-viable particle count dynamic and/or static testing for 25 Class Type All biological safety cabinets per ISO 14644 standard based on particles size of 0.5pm Provide certification and report for per ISO 14644 standard - Provide certification and report for biological safety cabinet per ISO 14644 Contractor's Service Report The service reports shall be furnished by the contractor and copies of the service reports shall be given to the Contracting Officer's Representative (COR) on a daily basic or as the work is completed. Unless otherwise instructed by the COR. - The Service Report shall also include, but not limited to the following: Name and address of testing organization • Test method/procedure reference • Date and time of test Identification of the individual performing test « Clear identification of area tested • Activity level at site during test « Equipment identification • Area classification Certification of Calibration for the instrument or equipment accordance with the manufacturer's instructions V. Labor and Travel The contractor shall provide all labor and travel at no additional cost the duration of the contract. VII. IT Security Concerns 1. Will the vendor install and/or the equipment/software/hardware on site at NIH? YES 2. How long will the vendor need to be on site? Depends on the complexity of the problem est. 6-8 hrs 3. Will the vendor have remote access to any system on site at NIH (e.g. patch management/trouble shooting, If so, what remote access technology will the vendor use? NO 4. Will the vendor have access (even inadvertently) to data on any NIH systems? NO 5. Will the vendor develop a system or hold NIH data off site (at vendor facility)? NO VIII. Contract duration: - November 1st, 2016 thru October 2017
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/17-000147/listing.html)
- Place of Performance
- Address: National Institutes of Health, Clinical Center/Office of Purchasing and Contracts, 6707 Democracy Blvd, Suite 106, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04297659-W 20161006/161004234650-0b901dbc20be451ddb5688d333e00819 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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