Contracting Office Address:
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES
Description:
National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch, plans to procure on a sole source basis off-site refrigerated and frozen storage, and shipping services for biological materials used by the Government for use in clinical trials, to be stored at the facilities of Fisher BioServices, Inc., 14665 Rothgeb Dr., Rockville, MD 20850, U.S.A.
This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 8.405-6(a)(1)(i)(B), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 493120 and the business size standard is $27.5M.
Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract issued via a GSA Task Order.
The period of performance is twelve (12) months from the date of award.
It has been determined there are no opportunities to acquire green products or services for this procurement.
The Surgery Branch of the National Cancer Institute is a combined laboratory and clinical research unit devoted to the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer. Initiatives include basic studies of cancer immunology and the conduct of clinical immunotherapy trials for patients with metastatic cancer.
Contractor shall provide the following:
(A) Facilities, material, and labor for storing cryopreserved cells or other frozen biologic material in three (3) Government-owned, liquid-nitrogen freezers (MVE freezer Model XLC 1520 HE S/N CNSR01K106, a Cryo Med 8152 Cryosafe SSBA III-NIH #01289370, and an additional Cryo Med 8152 Cryosafe SSBA III- NIH #01293900. Cells shall be stored at temperatures that meet the manufacturer's specifications for the freezer. Maintain racks in sufficient condition as not to damage the boxes during their removal and replacement in the racks to an extent that would allow vials to fall out of the boxes.
(B) Facilities, material, and labor for storing cryopreserved cells in additional Contractor-owned, liquid-nitrogen freezers dedicated to this contract, capable of storing vials with cryopreserved cells or other frozen biologic material (Nunc 1.8 ml vial; No. 377267) in up to 300 boxes (2.25 inches tall x 5.5 inches wide x 5.5 inches long, with at least 81 slots per box). The Government will provide the boxes. Cells shall be stored at temperatures that meet the manufacturer's specifications for the freezer. Maintain racks in sufficient condition as not to damage the boxes during their removal and replacement in the racks to an extent that would allow vials to fall out of the boxes.
(C) Facilities, material, and labor for storing biologic material at -80oC in one Government-owned freezer (Revco Model ULT2586-9-D14 NIH #01372627). The contractor shall provide additional freezer(s), dedicated to this contract, with shelving capable of providing up to approximately 60 cubic feet of -80oC storage space.
(D) Facilities, material, and labor for storing biologic material at -80oC in up to 60 cubic feet of additional Contractor-owned freezer space with shelving.
(E) Facilities, material, and labor for storing biologic materials and media supplies at
-20o C to -30oC in one Government-owned freezer (Revco ULT5030-A18, S/N T24-640219-UN.
(F) Facilities, material, and labor for storing biologic materials and media supplies in up to 20 cubic feet of additional, Contractor-owned, -20oC to -30oC freezer space with shelving.
The freezer chamber temperatures shall be monitored continuously and recorded at least several times an hour, seven days a week, 24 hours a day. Summary temperature records shall be provided monthly. When a chamber temperature falls outside of a specified range that is within the manufacturer's specifications, the Contractor shall have a monitoring system that, when triggered, shall result in a technician responding within sufficient time that corrective action can be taken to restore the temperature to its normal level. The technician's response shall prevent: 1) specimens stored in the liquid nitrogen chamber becoming warmer than -70oC, 2) specimens stored in the -80oC chamber becoming warmer than -50oC, and 3) specimens stored in the -20 to -30oC chamber becoming warmer than -5oC. The monitor and the power for the freezers shall be supported by an auxiliary system to provide backup in case of a power failure.
(G) Facilities, material, and labor for storing an average of about 20 cubic feet of tissue culture media supplies in +4oC refrigerator shelf space capable of holding up to a peak of about 40 cubic feet of tissue culture media supplies for two to three (2)-(3) days a month. The tissue culture media is primarily packaged in 10-liter bags, each of which is in 5.5 in. x 13.25 in. x 23.75 in. cardboard box.
The refrigerator temperatures shall be monitored continuously and recorded at least several times an hour, seven days a week, 24 hours a day. Summary records shall be emailed monthly to the Technical Point of Contact for the subsequent contract. When a chamber temperature falls outside of a specified range that is within the manufacturer's specifications, triggering of the monitoring system will result in a technician responding within sufficient time that corrective action can be taken to prevent liquids stored at +4oC becoming warmer than +15oC. The monitor and the power for the freezer will be supported by an auxiliary system to provide backup in case of a power failure.
All of the facilities for storing materials, described above, will meet industry standards, will be compatible with ISBER (International Society for Biological and Environmental Repositories) guidelines for facilities (http://www.isber.org/bp/), will have controlled access, and will be within a 30 minute drive from the main NIH Bethesda campus during non-rush hour conditions.
(H) Shipments, making and receiving, of biologic materials to and from the Surgery Branch facility (Surgery Branch; Bldg. 10CRC, Room 3W-3808; 10 Center Drive; Bethesda, MD 20892-1201) at the main NIH Bethesda campus. The Contractor will provide the delivery and pickup services for these shipments, requested by Surgery Branch staff on the Contractor's Authorized Users List, in coordination with the Technical Point of Contact for the subsequent contract.
In addition, GIBCO\Life Technologies, and potentially other established manufacturers of tissue culture media, will periodically ship media directly to the contract site. The Contractor shall store these materials at +4oC, until they are transferred to the Surgery Branch facility at the request of the Technical Point of Contact for the subsequent contract. GIBCO ships ten-liter bags of tissue culture media in close-fitting custom-made cardboard boxes, which are shipped at ambient temperature.
All shipments of frozen materials will be made in containers such that the combination of the container's insulation and amount of dry ice will assure that the temperature of the enclosed materials does not rise above that of dry ice during the shipment.
PREVENTIVE MAINTENANCE, REPAIRS, AND EMERGENCY SERVICE:
For Contractor-owned equipment, the Contractor shall carry out regular preventive maintenance that is consistent with the Manufacturer's guidelines. The Contractor shall monitor all Government provided equipment, and shall keep logs of any necessary preventative maintenance and repairs to any Government provided equipment. If Government provided equipment is noted to be in need of repair, the Contractor shall notify the Technical Point of Contact for the subsequent contract within 24 hours for resolution. Emergency repair services shall be provided by personnel, qualified by training and experience appropriate for the emergency, within 48 hours on an unlimited basis seven days a week, 24 hours a day, during the term of this service at no additional cost to the Government.
REPLACEMENT PARTS:
Replacement parts will be provided by the Government for Government-owned equipment. The Contractor shall supply replacement parts for its equipment used in the direct performance of this Statement of Work.
SERVICE EXCLUSIONS:
For Government-owned equipment the Contractor shall not be responsible for any repairs necessitated by vandalism, Acts of God, fire or water. These repairs will be the subject of a separate purchase order and will not be performed under this contract. The Contractor shall be responsible for its own equipment used in the direct performance of this Statement of Work.
PERIOD OF PERFORMANCE:
The period of performance of this contract is November 1, 2016 through October 31, 2017.
PERSONNEL QUALIFICATIONS:
Personnel shall have the education, training, and experience, or any combination thereof, to enable them to perform their assigned functions. Qualifications apply particularly to working with frozen biological specimens and maintaining these specimens at dry-ice temperatures or colder, when out of the freezer chamber.
CONTRACTOR FURNISHED SUPPLIES AND EQUIPMENT:
Liquid-nitrogen freezers, capable of storing vials with cryopreserved cells or other frozen specimens (Nunc 1.8 ml vial; No. 377267) in up to 300 boxes (2 to 2 1/16 in. tall with at least 81 slots per box);
Up to 60 cubic feet of -80oC freezer space with shelving capable of storing biologic material at -80oC;
Up to 20 cubic feet of -20oC to -30oC freezer space with shelving capable of storing biologic materials and media supplies and;
Up to 65 cubic feet of +4oC refrigerator space with shelving capable of storing up to forty-three 10-liter bags of media, which are in 5.5 in. x 13.25 in. x 23.75 in. cardboard boxes.
GOVERNMENT FURNISHED PROPERTY:
Three (3) Government-owned, liquid-nitrogen freezers (MVE freezer Model XLC 1520 HE S/N CNSR01K106, a Cryo Med 8152 Cryosafe SSBA III-NIH #01289370, and an additional Cryo Med 8152 Cryosafe SSBA III-NIH #01293900);
One (1) -80oC Government-owned freezer (Revco Model ULT2586-9-D14 NIH #01372627) and;
One (1) -20o C to -30oC Government-owned freezer (Revco ULT5030-A18, S/N T24-640219-UN.
PAYMENT:
Payment shall be made monthly in arrears after receipt and acceptance of the services. The invoices shall list the services provided each month, including facilities, materials, labor, and the number and types of shipments, using the same line item service identifications used in the contract.
CONTRACT TYPE:
This will be awarded as a Firm Fixed Price type contract in aggregate.
This service is provided by Fisher BioServices. The proposed source is the only known Vendor that is within the required geographic proximity that can perform all the technical requirements stipulated in the SOW. The Surgery Branch has used this Vendor with their specific services for many years to support its on-going clinical trials. Because the clinical trials that the Surgery Branch supports are on-going, the specified performance characteristics and quality of the needed services are required for maintaining the scientific integrity of those on-going trials. A change would be disruptive to the ability to seamlessly continue supporting the clinical trials, and subsequently those patients enrolled in them that receive the cell therapies derived from the unique biomaterials being stored in the proposed Vendor's biorepository.
This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities 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 3:30PM EDT, on October 18, 2016. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02RC79999-76 on all correspondence.
