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CONTROL SET, BLOOD CHEM

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SPE2DS-27-T-1747Federal

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This procurement is for a Control Set, Blood Chemistry (NSN 6550-01-670-0237), specifically the EightCheck-3WP X-Tra. This stabilized whole blood matrix control is designed for the statistical process control of Sysmex hematology analyzers and monitors up to 22 parameters. The product is issued as a set of 12 total vials, consisting of a tri-pack with low, normal, and high levels (4 vials per level), with each vial containing 2.0 ML of product. The material consists of stabilized human erythrocytes, mammalian and simulated leukocytes, and a platelet component in a plasma-like medium. It requires refrigerated storage between 2 to 8 degrees Celsius and must not be frozen. The contract specifies a strict shelf life of 3 months, with a requirement that no more than 13 days elapse from the date of manufacture to the date of delivery. Delivery is required within 20 days to Fort Campbell, Kentucky, with inspection and acceptance occurring at the destination. Packaging must comply with DLA Master List of Technical and Quality Requirements and Medical Marking Standard No. 1, which supersedes MIL-STD-129. The solicitation is governed by various FAR and DFARS clauses, including destination inspection, the Buy American Act, and cybersecurity reporting requirements. Invoicing must be processed electronically through the Wide Area WorkFlow system.

General Info

Procurement of EightCheck-3WP X-Tra blood chemistry control sets for delivery to Fort Campbell.

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

BLDG 5505A WICKHAM AVE, FORT CAMPBELL, KY, 42223-5000, USA

Set-Aside

NONE

Documents

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Timeline

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PhaseSolicitation
Posted

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Contacts1 person available
OfficeUSA

Full Description

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CONTROL SET,BLOOD CHEMISTRY
CONTROL SET, BLOOD CHEMISTRY
FEATURES EIGHTCHECK-3WP X-TRA IS A STABILIZED
WHOLE BLOOD MATRIX CONTROL DESIGNED FOR STATISTICAL PROCESS CONTROL OF
SYSMEX HEMATOLOGY ANALYZERS. TRI-PACK CONSISTS OF 3 LEVELS LOW, NORMAL
AND HIGH. THERE ARE 4 VIALS FOR EACH LEVEL.
EACH VIAL CONTAINS 2.0 ML OF PRODUCT. CONTROLS MONITOR UP TO 22
PARAMETERS AND CONSISTS OF STABILIZED HUMAN ERYTHROCYTES, MAMMALIAN AND
SIMULATED LEUKOCYTES, AND A PLATELET COMPONENT
IN A PLASMA-LIKE MEDIUM.
REQUIRES REFRIGERATION STORAGE BETWEEN 2 TO 8 DEGREES CELSIUS
(36 TO 46 DEGREES FAHRENHEIT) DO NOT FREEZE
UNIT OF ISSUE SE (SET OF 12 TOTAL, 4 VIALS FOR EACH LEVEL)
..
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.
SPE2DS-27-T-1747
SECTION B
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO Sign up to see this detail. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
..
RS005: Shelf-life requirement RS001 for a TYPE I (CODE C) item with a shelf life of 3 months (non-extendable) applies to this item.
SHALL HAVE A SHELF LIFE OF 3 MONTHS. NOT MORE THAN 13 DAYS 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. .. ADEQUATE DATA FOR THE NSN/Part Number: 6550-01-670-0237 Quantity: 1 SE Purchase Request: 7019116763QTY: 1 Delivery: 20 days ADO

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