PERFORMANCE WORK STATEMENT-Panther Equipment_Redacted.pdf

STATEMENT OF WORK

Preventive Maintenance of Procleix Panther Nucleic Acid Test System Analyzer Equipment

Pacific Command Armed Services Blood Bank Center U. S. Naval Hospital Okinawa

BACKGROUND

Pacific Command (PACOM) Armed Services Blood Bank Center (ASBBC) is one of two DoD blood donor testing laboratories. PACOM ASBBC is mandated to screen donated blood in order to produce FDA-licensed blood products for the Indo-Pacific region. The Procleix Panther analyzer is an FDA cleared and approved platform for testing HIV RNA, HCV RNA, HBV DNA, and West Nile Virus RNA, and Babesia, utilizing Nucleic Acid Testing. The analyzer requires annual onsite maintenance not available from Biomed resources within U.S. Naval Hospital Okinawa (USNHO). This Statement of Work (SOW) details the effort that must be undertaken to support the continuous operation and maintenance of the analyzer.

GENERAL SCOPE OF WORK

The contractor shall provide telephone technical support, onsite emergency maintenance and onsite preventive maintenance (PM) services for the PROCLEIX PANTHER Nucleic Acid Test system. The contractor shall provide qualified technicians; Original Equipment Manufacturer (OEM) replacement parts;

perform system calibrations; and provide all supervision, equipment, supplies and transportation for technicians to maintain the equipment.

DETAILED WORK REQUIREMENTS

The contractor shall provide the following support.

PREVENTIVE MAINTENANCE

Preventive maintenance shall be performed every six (6) months. The contractor shall provide one (1) qualified technician to PACOM ASBBC in Okinawa, Japan to perform preventive maintenance. The duration of each trip shall take about three (3) days. The preventive maintenance shall include:

1. Thorough check up

2. Preventive maintenance shall be done according to the Novartis Preventative Maintenance Checklist for the PROCLEIX PANTHER System to include external decontamination, inspection of internal modules, checking for leaks or damage, internal decontamination, vacuum pump inspection, pipettor cleaning and calibration, fluidics inspection, luminometer inspection, UPS battery checks, and replacement of parts as needed.

3. The contractor shall file all preventive maintenance checklists completed on the PROCLEIX PANTHER System for all preventive maintenance, remedial repairs or emergency repairs and ensure the PM checklist comments/corrective action comments are detailed, completed, and signed by contractor’s technician and by the Technical Representative (TR). The Contractor shall develop, within two weeks after award, a Preventive Maintenance schedule that lists the dates and items for those Preventive Maintenance service.

TELEPHONE TECHNICAL SUPPORT

Telephone support shall be available from 0700 to 1600 Japan Standard Time, Monday to Friday. The Contractor shall provide telephone support for troubleshooting instrumentation and reagents through the customer support center. The contractor shall also provide technical support beyond office hour via email.

The contractor shall create a record of service calls to allow consolidated reporting of all services activities.

Based on past history, there will be approximately sixty (60) trouble shooting inquiries annually. The total inquiry time annually is approximated at thirty (30) hours.

UNSCHEDULED MAINTENANCE CALLS

The Contractor shall provide unscheduled maintenance services. Coordination shall be managed by the specialist, who are trained and certified by Grifols to ensure that on site work is completed to U. S.

standards and accepted by the Government. A qualified technician should be dispatched within seven (7) working days for any unscheduled maintenance.

Based on past history, there will be approximately two (2) trips annually. The total working time annually is approximately thirty-two (32) hours.

REPLACEMENT/REPAIR PARTS

The Contractor shall furnish only Original Equipment Manufacturer (OEM) parts to affect all replacements or repairs. The Contractor shall bear all costs associated with obtaining the parts. The Contractor shall have available or access to all parts necessary for the accomplishment of the service within the time frames set for repairs. All parts installed shall become the property of the Government and the contractor shall dispose the replaced parts properly.

MAINTENANCE RECORD

The Contractor shall furnish a signed System Maintenance Record written in English to the donor center and hospital upon completion of each maintenance (preventive and corrective) service and for each service call placed. The TR shall countersign the report to certify that services were rendered. The Contractor shall maintain a copy on file and shall submit one copy to the TR for verification immediately following the services. An additional copy of the maintenance record shall be attached to the monthly invoice.

As a minimum, the following information shall be included on each System Maintenance Record:

a. time and date the Contractor was notified.

b. contract number, time and date the Contractor’s maintenance personnel arrived, including the name(s) of each of the Contractor’s employees present.

c. type, model and serial of the equipment.

d. description of the services requested or problem, and of the services actually performed by the Contractor.

e. time spent for repairs.

f. list of parts, which the Contractor replaced, including part number and serial number of each part.

g. list of software, which the Contractor repaired, replaced or upgraded including software version and the serial number of software item.

h. time and date the Contractor returned the system to the Government in operating condition.

i. signature of TR (if services are completed during normal duty hours).

j. signature lines of Contractor and designated government representative.

TRAVEL AND ACCOMODATION

The contractor shall be responsible for all travel and travel related costs (lodging, airfare, per diem, etc.).

Travel and accommodations shall be arranged by the contractor.

CONTRACTOR’S RESPONSIBILITIES

The Contractor shall provide a point of contact and phone number(s) to which requests for services may be made e.g. trouble desk, answering machine or email address.

In all instances where Government property or equipment is damaged by the Contractor’s employees, a full report of the facts and the extent of the damage shall be submitted to the TR within 24 hours following the occurrence. The TR shall then forward the report to the Contracting Officer within 24 hours of receipt.

The Contractor shall provide a one-week advance notification to the TR before performing any quarterly scheduled preventive maintenance.

CONTRACTOR’S PERSONNEL

The Contractor shall furnish sufficient qualified technicians who have been trained and certified by the OEM Grifols and/or an equivalent independent service organization-training program that is approved by Grifols. Formal training background shall include, as a minimum, performance of preventive and corrective maintenance on the equipment, with a thorough working knowledge of each system’s hardware and software. The contractor shall provide a list of qualified service personnel to the TR and shall keep him updated shall there is any change.

All technicians shall wear an identification tag that identifies them by name and identifies the Contractor’s name. The tag shall be printed in English and shall be visible at all times while performing services at PACOM ASBBC USNH Okinawa.

GOVERNMENT RESPONSIBILITIES

Government personnel shall not perform maintenance or attempt repairs to the equipment while the equipment is covered under this maintenance contract.

The Government shall permit the Contractor access to the equipment to be maintained and provide ample workspace for the maintenance.

The Contracting Officer shall furnish to the Contractor the names of the TR who are authorized to place service calls. Any service rendered by the Contractor without approval of one of those individuals will be at the Contractor’s own expense and the Government will not pay for the service.

The government will issue all required base passes to Contractor personnel at no cost to the Contractor.

PERIOD OF PERFORMANCE

Base Year PoP: 24 Aug 2025 – 23 Aug 2026 Option Year 1: 24 Aug 2026 – 23 Aug 2027 Option Year 2: 24 Aug 2027 – 23 Aug 2028 Option Year 3: 24 Aug 2028 – 23 Aug 2029 Option Year 4: 24 Aug 2029 – 23 Aug 2030

PLACE OF PERFORMANCE

PACOM ASBBC Bldg. 968 Camp Foster, Okinawa, Japan

End Statement of Work