Notice_of_Intent_4149090.doc

General Information

Short Title: Tissue culture technician support services.

Document Type:

Notice of Intent Solicitation Number:

N02CO62623-78

Posted Date: 8/9/2016 Response Date: 8/12/2016 10 AM ET Classification Code: R499

NAICS Code: 541990

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD 20850, UNITED STATES

Description

National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch, plans to procure on a sole source basis under the Women-Owned Small Business Program sole source awards, tissue culture technician support services, from Ganges, Mary Bruce Biological Research, 11710 Old Georgetown Rd. Unit 102, Rockville, MD 20852-2677.

This acquisition will be processed in accordance with FAR 19.1506 (b), under the authority of paragraph (a)(3) of section 825 of the Carl Levin and Howard P. “Buck” McKeon National Defense Authorization Act for Fiscal Year 2015, Pub. L. 113-291.

The North American Industry Classification System code is 541990 and the business size standard is $15 Million.

Only one award will be made as a result of this notice. This will be awarded as a IDIQ with firm fixed price orders.

The period of performance is 5 years from award date or August 20, 2016.

It has been determined there are no opportunities to acquire green products or services for this procurement.

Contractor Requirements are:

Purpose:

The purpose of the professional service support requested here is to continue the flexible, high-quality tissue culture technician support needed to generate cells used in the Branch’s twenty-two currently active Adoptive T-cell therapy clinical trials for patients with advanced cancer. The Contractor shall support tissue culture tasks by providing flexible, “on demand” media preparation, tissue processing support, highly specific, cell-culture procedures during periods of high laboratory through-put, as well as maintenance of laboratory records associated with the contract work.

Technical Considerations:

1.

Carrying out basic and advanced tissue culture procedures, preparing tissue culture media—including serum from freshly collected human blood, establishing and maintaining human cell lines, and cryopreserving human cells.

2.

Applying sterile laboratory techniques.

3.

Tending to the biosafety cabinet used by the contractor for supporting tissue culture procedures.

4.

Autoclave use.

5.

Applying Universal Precautions for work with human tissues.

6.

Using Microsoft Outlook and Word software.

7.

Maintaining detailed records of generated products and assigned personal equipment maintenance, which comply with FDA regulations and established laboratory procedures for preparing tissue culture reagents that support patient treatments used in Surgery Branch clinical trials.

Tasks:

1.

Prepare customized tissue culture media according to established laboratory procedures provided for the Contractor. The Contractor shall prepare media as communicated by the supervisor or designee on an “as needed” basis. Detailed records will be kept on worksheets and in established computer databases, provided as needed by the laboratory.

2.

Process serum for use in tissue culture media, including human serum on an “as needed” basis. Processing steps involve heat-inactivation, serum filtration, and aliquoting the final product.

3.

Prepare viable cells from human tissues, including tissue processing, culture initiation, culture expansion, and cryopreservation of human cells, using established laboratory procedures provided for the Contractor.

4.

Establish and maintain human tissue culture lines, including regular assessment of the cultures by microscopic inspection and counting cells, splitting cultures, changing tissue culture medium, and thawing and cryopreserving cells. Established laboratory procedures shall be provided for the Contractor.

5.

Assemble approved materials, as needed, for carrying out specific clinically-directed tasks in the Cell Production Facility clean-room laboratory.

6.

Maintaining assigned detailed records of supplies, generated products and equipment maintenance, which comply with FDA regulations and established laboratory procedures.

Reports:

1.

The Contractor’s electronic and hard-copy record of each product generated, including the date it was generated and other information specified in the laboratory standard operating procedures.

2.

Invoices that contain work records of the starting and ending times of billable work each day.

Deliverables:

1.

Material products generated by the Contractor (e.g., media, sera, cells) shall be delivered in appropriately labeled containers to the supervisor, designee(s), or predetermined destination (e.g., specific storage location).

2.

Detailed records kept on laboratory worksheets in binders and databases shall be available for the supervisor and designees.

3.

Contractor shall relate to the supervisor or designee, topics arising in advanced training sessions that could be of interest for discussion at one of the weekly general laboratory meetings.

4.

Contractor shall provide time cards as required by the Contracting Officer or the Technical Point of Contact.

Schedule:

Milestones will be determined by the dates deliverables (see above) are provided. The last milestone will be at the end of the contract year.

Government Property:

The Government will provide all laboratory space, consumables, equipment, and established laboratory protocols for each of the basic tasks. Work will be carried out in Surgery Branch laboratory space in the Clinical Center at the main NIH campus in Bethesda, MD.

Level of Effort:

The effort will be quantified by the technician’s hours of labor, which will be up to 40 hours per week, not to exceed 1800 hours per year (a total of 9000 hours for the entire POP), with a minimum of 1 hour for the entire POP. The hours will fluctuate, depending on the tissue culture needs for supporting the Surgery Branch Adoptive T-cell therapy clinical trials.

As the Contract is an IDIQ, the level of effort will be set under individual task orders.

Quality Assurance:

Contractor Quality Requirements:

The Contractor shall carry our quality control procedures for the generated products and shall maintain laboratory records for these services, using both hard copy and computer formats in Microsoft Excel or Word that meet standard laboratory record keeping and requirements associated with generating products for treating patients enrolled in clinical protocols.

The Contractor shall review the requirements and get clarification if needed. The Contractor shall function with a high level of independence in carrying out the tasks described above.

The Contractor shall have the responsibility for organizing and carrying out work and for quality control of the products generated. Inspection and acceptance of tissue culture media and cells will be performed by the Technical Point of Contact.

Qualifications:

The proposed technician shall have a college science degree and a minimum of 5 years of work experience in the task (or equivalent) that are to be completed under this contract.

This notice is not a request for competitive quotation. However, if any interested party, EDWOSB or/and WOSB, believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 10 AM ET, on August 12, 2016. All responses and questions must be via email to Francisco Mendoza, Contracting Officer at francisco.mendoza@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification and the Online Representations and Certifications Applications through sam.gov. Reference: N02CO62623-78 on all correspondence.