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CONTROL SET, BLOOD CHEM

Active
SPE2DS-26-T-395VFederal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This contract is for the procurement of one set of i-STAT TBI calibration verification materials, consisting of six vials of frozen serum across three levels. The product must be stored at negative 20 degrees Celsius and is subject to a strict six month non-extendable shelf life, with a requirement that no more than two weeks pass between the date of manufacture and delivery to the government. The supplier must adhere to DLA packaging and medical marking standards, ensuring all units are sealed and protected from damage. Compliance with the Hazard Communication Standard is required, including the submission of Safety Data Sheets and specific labeling in accordance with OSHA and federal regulations. Delivery is required within five days after receipt of the order.

General Info

Procurement of i-STAT TBI calibration materials with strict storage and delivery requirements.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSFView Agency

NAICS

325413 - In-Vitro Diagnostic Substance ManufacturingView NAICS

Place of Performance

USA

Set-Aside

NONE

Documents

(1)

SPE2DS-26-T-395V.pdf

PDF

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Timeline

PhaseSolicitation
Posted

Solicitation

Response Deadline

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Contacts1 person available
OfficeUSA
Organization / Agency
Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
View Agency Profile
Office AddressUSA
Contacts
Mary-Kathryn Donahue
contact@example.gov
+1 (555) 000-0000

Full Description

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CONTROL SET,BLOOD CHEMISTRY
CONTROL SET,BLOOD CHEMISTRY
FEATURES I-STAT TBI CALIBRATION VERIFICATION SET LEVELS 1-3;
A COMPREHENSIVE SET OF AQUEOUS MATERIAL USED FOR CALIBRATION
VERIFICATION OF THE I-STAT TBI TEST CARTRIDGE
MUST BE KEPT FROZEN AT NEGATIVE 20° CELSIUS (-4° FAHRENHEIT)
UNIT OF ISSUE: SE (SET OF 6 VIALS, TWO VIALS OF EACH LEVEL, LEVELS 1, 2,
AND 3; EACH VIAL CONTAINS 1 ML OF FROZEN SERUM)
..
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS
(IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE
DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB
AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
..
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
..
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
..
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
..
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS
SPECIFIED IN THE PROCUREMENT DOCUMENT.
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED
IN A SUITABLE SEALED UNIT CONTAINER CAPABLE
OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR
BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
SPE2DS-26-T-395V
SECTION B
..
RS008: Shelf-life requirement RS001 for a TYPE I (CODE F) item with a shelf life of 6 months (non-extendable) applies to this item. SHALL HAVE A SHELF LIFE OF 6 MONTHS. NOT MORE THAN 2 WEEKS SHALL HAVE ELAPSED FROM DATE OF MANUFACTURE TO DATE OF DELIVERY TO THE GOVERNMENT. . SHELF LIFE MARKINGS SHALL BE IN ACCORDANCE WITH THE LATEST REVISION OF MMS1C.
. ALL LABELS SHALL INCLUDE:
DATE OF MANUFACTURE, EXPIRATION, OR RETEST DATE CONTRACT NUMBER/LOT NUMBER. .. RQ034: HAZARDOUS COMMUNICATION STANDARD NOTICE
Hazard Communication Standard Notice:
Effective June 1, 2015, Federal Standard No. 313-E, Material Safety Data, Transportation Data and Disposal Data for Hazardous Materials Furnished to Government Activities, establishes the requirement for preparation and submission of Safety Data Sheets (SDS) in lieu of Material Safety Data Sheets (MSDS) by suppliers who provide hazardous materials to government activities.
The Occupational Safety and Health Administration (OSHA) has modified its Hazard Communication Standard (HCS) to conform to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals. As a result of this change, GSA revised Federal Standard No. 313-E requiring Safety Data Sheets for classifying chemicals and communicating the applicable information on labels.
In accordance with the revised standard after June 1, 2015:
1. Suppliers will be required to submit, to the contracting officer for review and approval prior to award, safety data sheets consistent with the requirements found at 29 C.F.R. 1910.1200 for hazardous materials delivered to the Government.
2. Suppliers will also be required to submit, to the contracting officer for review and approval prior to award, Hazardous Communication Standard (HCS) labels in accordance with 29 C.F.R. 1910.1200 requirements or current Consumer Product Safety Act (CPSA), Federal Hazardous Substance Act (FHSA) labels when subject to labeling requirements under those statutes. This product labeling is required for hazardous materials delivered to the Government.
3. Finally, suppliers must train their employees on the new safety data sheets, hazardous communication labels, and requirements of 29 C.F.R. 1910.1200.
For more information on SDS, refer to OSHAs website, available at:
https://www.osha.gov/law-regs.html
For information on 29 C.F.R. 1910.1200, refer to the below link:
https://www.osha.gov/dsg/hazcom/index.html .. ADEQUATE DATA FOR THE NSN/Part Number: 6550-01-693-9107 Quantity: 1 SE Purchase Request: 7018150117QTY: 1 Delivery: 5 days ADO

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