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RFI FBO - High-performance liquid chromatography (HPLC) PM


Arizona, United States
Government : Federal
RFI
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THIS IS A SOURCES SOUGHT NOTICE:
This is NOT a request for proposals; this is an inquiry for Market ********* A solicitation shall not be issued at this time. The intent of the *********** is to locate contractors for The below ************* defines the effort required for the ******** and period of performance.

PERFORMANCE WORK STATEMENT
1. VA FACILITY:
Cooperative Studies Program
Clinical Research Pharmacy Coordinating Center
New Mexico VA Health Care System
Albuquerque, New Mexico
2. TITLE:
High-performance liquid chromatography (HPLC) Maintenance
3. BACKGROUND:
The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center in Albuquerque, NM supports the conduct of clinical studies throughout the Department of Veterans Affairs. B Part of this effort involves testing pharmaceutical products used in the studies to ensure patient safety is protected through various chemical analyses. B PM of Agilent equipment and receiving annual validation is critical for testing and is required under cGMP and ISO guidelines.
4. SCOPE:
This requirement is for *********** Agilent CrossLab Silver with Operational Qualification/Repair Qualification (OQ/RQ) services for the Agilent Technologies equipment listed in this document. B The contractor shall perform an annual preventative maintenance visit, validate the equipment for use, and throughout the rest of a performance period shall provide telephone support and repair services as necessary and as contained in the requested level of support Agilent CrossLab Silver with OQ/RQ.

5. SPECIFIC TASKS:
a. Service technicians shall be certified on/by Agilent Technologies equipment to perform any services/maintenance on the enclosed specified equipment. Contractor shall provide documentation/copy of certification with proposal submittals and upon award.
b. Provide Agilent CrossLab Silver with OQ and RQ for equipment listed in the enclosed PWS paragraph 5.t.
c. The Contractor shall provide standard service to include telephone support to isolate; resolve hardware/software problems; Service Center Repair; on-site hardware troubleshooting and fully certified/validated repair no later than 5 business days or sooner.
d. Contractor shall provide unlimited on-site repair services to restore equipment to optimal
operating conditions.
e. The Contractor shall include all labor, travel costs, service parts, and including consumable parts required for repair. All parts shall be Original Equipment Manufacturer (OEM) parts are to be of manufacturer or equivalent and fully compatible with current Agilent equipment.
f. The Contractor shall include one Agilent CrossLab Preventative Maintenance Program.
g. The Contractor shall include one Agilent CrossLab Operational Qualification/Performance Verification (OQ/PV) and Agilent CrossLab Repair Qualification (RQ).
h. PM OQ service shall consists of system testing using a chemical test sample kit of known concentration to verify proper equipment operation; also, software tools are used as part of the process. Contractor shall configure test parameters according to the Government s requirements.
i. Contractor shall utilize a checklist for each step of protocols in accordance with manufacturer s recommendations.
j. Service technician shall Repair Qualification that recertifies equipment after a repair has occurred.
k. If offers proposed service is not the requested Crosslab Silver with Operational Qualification/Repair Qualification (OQ/RQ), proposal shall include sufficient details for comparison during technical review.
l. Annual preventive maintenance shall be completed when scheduled and validation documentation provided. Validation of equipment shall be completed immediately after PM services. Validation shall be performed on all equipment on an annual basis and within the same month of the last service certification date and in such a way that validation does not expire.
m. Contractor shall provide recertification/validation verification and equipment validation report to SME/COR in an electronic format. Files shall be in PDF format and shall be electronically delivered to the SME/COR
n. Equipment Shall be fully RQ requalified no later than 24-hours after repairs. Shall ensure the equipment remains continuously in conformance with the *************s used.
o. Contractor shall provide a 100% service repair guarantee. The equipment shall be repaired or replaced with equivalent equipment. Parts shall be of OEM; refurbished, used, or grey market parts shall NOT be accepted. Equipment replacement shall require written modification to the task order.
p. Normal wear and tear items, such as liners, seals, lamps, and tubing, shall be included when needed to complete repairs.
q. On-site emergency repair response shall be performed, validated and recertified no later than 48-hours of service call. (non-business days do not count in this time period since user is closed on Federal Holidays/Weekends)
r. All preventive maintenance, corrective maintenance, emergency repairs, and validations shall be performed by a fully trained and certified Field Service Engineer (FSE).
s. The Contracting Officer (CO) may request proof of training and certification, from the Contractor, at any time during the period of performance.
t. Equipment to be supported
System Name
Serial Number
Model Description
Frequency of Service
Last Calibration Date (tracked by System vs Sub-component)
1290 UPLC
SYSTEM 1
B
LC 1290 System


B
DEBAF03769
1290 Infinity
Diode-Array Detector
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAC09789
1290...

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