Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF SEPTEMBER 02, 2023 SAM #7949
SPECIAL NOTICE

J -- leukocytes and plasma from human subjects

Notice Date

8/31/2023 6:01:48 PM
 

Notice Type

Special Notice
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

NAVAL MEDICAL RESEARCH CENTER SILVER SPRING MD 20910-7500 USA
 

ZIP Code

20910-7500
 

Solicitation Number

1301087302
 

Response Due

9/14/2023 7:00:00 AM
 

Archive Date

09/29/2023
 

Point of Contact

Nataki Johnson Lovett, Phone: 3013196481, Deborah M. Sharpe, Phone: 3013196471
 

E-Mail Address

nataki.s.johnsonlovett.civ@health.mil, deborah.m.sharpe2.civ@health.mil
(nataki.s.johnsonlovett.civ@health.mil, deborah.m.sharpe2.civ@health.mil)
 

Description

The work to be conducted consists of on-site apheresis sessions to remove leukocytes and plasma from human subjects for use in the development of new assays supporting the development of vaccines for infectious diseases by the scientists at US Military Research Programs. The availability of large amounts of leukocytes and plasma from screened human subjects provides a consistent and vetted supply of white blood cells for the development of vaccines. The performance terms, qualities and attributes of the service are listed below. 1. Provide apheresis service(s) in accordance with generally recognized standards of care as outlined by federal, state, and local applicable laws and regulations, to subjects enrolled in studies at NMRC Clinical Trials Center. These services will include necessary staff, equipment, and supplies.a. Provide prompt delivery of the apheresis system which will remain at the NMRC-Clinical Trials center for specified days to facilitate goals of the IRB-approved project. Maintenance includes repair and/or replacement of the apheresis machine as necessary for provision of services. b. The vendor will work with the CTC Director on the timeline when the apheresis machine shall remain at the CTC and how scheduling shall be arranged for transport and staffing. Additionally, the vendor shall specify how and by whom the consistent availability of the apheresis nurse during the time the machine is at the CTC shall be arranged. c. Provide the appropriate Apheresis Kits (or equivalent, based on apheresis system) for the scheduled procedure, saline and ACTH solution bags in the appropriate concentration and amount for each procedure. d. Provide properly trained and qualified personnel and/or consultant(s) in adequate number(s) to perform apheresis, as specified in the protocols i.e. technicians, nurses, doctors. e. Upon request, provide information and documentation regarding the licensure, certification, and experience of all personnel. The personnel shall meet all regulatory requirements to be in contact with subjects at the NMRC-CTC. f.. Shall meet, as reasonably requested, with study investigators to discuss matters affecting provisions of services. SOP(s) and QA procedures will be in place prior to study initiation that is agreed to by both parties. 2. Provide clear and detailed invoices at a minimum of every three months.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/fb51d04992164672864e011d8a224df1/view)
 

Place of Performance

Address: Silver Spring, MD 20910, USA

Zip Code: 20910

Country: USA
 

Record

SN06814277-F 20230902/230831230055 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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