PWS_Hematology_1Apr21.pdf

DEPARTMENT OF THE ARMY

U.S.ARMY MEDICAL DEPARTMENT ACTIVITY JAPAN

UNIT 45011 APO AP 96343-5011

PERFORMANCE WORK STATEMENT

FOR

PREVENTIVE MAINTENANCE

INSPECTION & REPAIR SERVICE FOR

HEMATOLOGY ANALYZER

AT BUILDING 704

CAMP ZAMA, JAPAN

1 Apr 2021

Attachment to FA520921Q0042

TABLE OF CONTENTS

SECTION 1 Description of Services / General Information Page 2

SECTION 2 Services Summary Page 8

SECTION 3 Appendix Page 9

SECTION 1

DESCRIPTION OF SERVICES/GENERAL INFORMATION

1.0. DESCRIPTION OF SERVICES. The contractor shall provide all necessary labor, personnel, supervision, management, tools, equipment, transportation, materials, and any other items or services necessary to perform semi-annual preventive maintenance inspection (including semi-annual calibrations) and on-call repair services for the EXISTING Hematology Analyzer (Maker: Beckman Coulter, Model: DxH 800) at Building 704, Camp Zama, Japan. The contractor shall perform in accordance with (IAW) this Performance Work Statement (PWS), commercial standards and practices, and the manufacturer’s specifications.

1.1. INSPECTION AND MAINTENANCE, EXPECTED REPAIR.

1.1.1. The contractor shall perform inspection and maintenance as required for each specific piece of equipment listed in Appendix A, to include but not limited to cleaning, dusting, lubrication, change of lubrication fluids, adjustment, testing, and calibration to ensure equipment is in proper operating condition. All expected consumable parts required for inspection and maintenance shall be provided by the contractor. The contractor shall not change any equipment configuration without Government Representative (GR) approval.

1.1.2. Semi-Annual Maintenance Schedule. The contractor shall submit a semi-annual maintenance schedule to the GR within 10 business days after contract award and by the start date of each option year for GR approval prior to performance. The annual schedule shall show the order in which the contractor proposes to perform the inspection and maintenance services, the dates on which the contractor will start each work element, and the scheduled completion date for each element. The contractor shall not deviate from the approved schedule without permission from the GR.

1.1.3. Inspection and Maintenance Report. The contractor shall provide a semi-annual inspection and maintenance report written in English to the GR within 10 business days after the completion of each performance period. The report shall include the following information:

(1) Listing of equipment serviced (Maker, Model, etc.)

(2) Name of technician who performed

(2) Date and time of the service performed

(3) Description and method of service performed

(4) Conditions of serviced equipment

(5) Detailed list of parts replaced and/or total man-hours of work performed

(6) Contract Manager’s signature

1.1.4 EXPECTED REPAIRS.

1.1.4.1 Expected Repair work includes the reprocessing or replacement of parts or materials which have deteriorated and could not have been corrected through maintenance servicing, but was identified as likely to fail or break. All repairs may be identified during routine maintenance service or during an on-call service. Repair work may also be required for correction of conditions and equipment that adversely affects the use of system for designated purpose as well as to restore any failed or failing components.

1.1.4.2 In the event that the contractor identifies needed repairs (expected or unexpected) during maintenance service, the contractor shall immediately inform the GR and take temporary measures to ensure safety and to minimize/prevent further damages to the equipment. Additionally, the contractor shall submit a deficiency report in both English and Japanese to the GR of each installation within five

(5) business days of the findings. The deficiency report shall include, at a minimum, the following information:

(1) Detail information of the equipment (Maker, Model, etc.)

(2) Finding date of failure

(3) Detailed description of failure (pictures, drawings, etc.)

(4) Detailed description of repair work, material list, and man-hours for repair

(5) Proposed repair schedule and estimated downtime for repairs

(6) Submission date of the report

(7) Contract Manager’s signature

1.1.4.3 The contractor shall provide on-call repair services, initially by means of telephone technical support, Monday thru Friday, 0900-1730. When on-call repair services are requested on Japanese holidays, the contractor shall provide on-call repair services using CLIN x002. If the issue cannot be resolved through telephone technical support, the contractor shall dispatch a technician within 72 business hours (except for unexpected repairs) from the GR’s repair request. If the contractor is unable to meet the 72 hour requirement, the contractor shall notify the GR. The contractor shall report to the work location, survey, perform minor repairs, and restore the equipment and/or systems to the maximum extent practicable. If the repair is unable to be made at the time of the response, the contractor shall immediately take temporary measures to ensure safety and to minimize/prevent further damages to the equipment as well as submit a deficiency report to the GR within five (5) business days.

1.1.4.4 The contractor shall accomplish the repair work IAW the approved schedule.

1.1.4.5 Repair Report. The contractor shall prepare and submit a written report within five (5) business days after the scheduled repair is accomplished. This report shall include the date, time, and service performed, etc. If the service performed did not follow the schedule, the contractor shall document the reasoning in the report.

(1) Date and time of repair performed

(2) Detail information of the equipment (Maker, Model, etc.)

(3) Detailed description of repair work, material list, and man-hours for repair

(4) Name of the technician performing repair services

(5) Contract Manager’s signature

1.2. INTERFERENCE WITH GOVERNMENT OPERATIONS. The contractor shall make every effort to schedule its maintenance activities so as not to interfere with U.S. Government operations. In the event the nature of the work makes such interference necessary, the contractor shall provide the GR with a minimum of ten (10) business days advance notification of the proposed work.

2.0. GENERAL INFORMATION.

2.1. CONTRACTOR PERSONNEL.

2.1.1. Contract Manager. The contractor shall provide a contract manager who shall be responsible for all requirements in this PWS. The name of this person and an alternate(s) who shall act for the contractor when the manager is absent, shall be designated in writing to the GR. The contract manager or alternate shall have full authority to act for the contractor on all matters relating to this contract. The contractor shall provide the contract manager’s names, addresses, and telephone numbers. The contractor shall maintain a current listing of employees, providing updates as changes occur. The contract manager or alternate shall be proficient in English and have a good understanding of the requirements pertaining to this contract for interpretation and implementation of directives (written and oral), issued in English by the KO or GR. If the contract manager or alternate do not meet these requirements, the contractor shall provide a translator for them.

2.1.2. Contractor Employees. Contractor personnel shall be easily recognizable as contractor employees.

This may be accomplished by wearing distinctive clothing bearing the name of the company or by wearing appropriate badges which contain the contractor’s company name and the employee’s name.

2.1.2.1. Personnel Qualifications. The contractor shall be responsible for their employees have the following current and valid professional certification for the entire life of this contract; “Field Service Training Certificate”, issued by the Beckman Coulter K.K. A copy of the certificates or permits must be submitted prior to contract award.

2.1.3. Removal of Contractor’s Employees. The contractor shall utilize only experienced, responsible and capable employees in the performance of this contract. The KO may require that the contractor remove any of his/her employees who endanger persons or property, or whose continued employment under this contract is inconsistent with the interests of the U.S.Government.

2.1.4. Other Country Nationals (OCN). The security forces on each base control entry to the base. Under certain circumstances, the OCN might be denied entry. It is the contractor’s responsibility to coordinate with security forces at each base when there is a question about particular entry circumstances.

2.1.5. U.S. Government and/or Master Labor Contract Employees. The contractor shall not hire employees of the U.S. Government and/or Government of Japan Master Labor Contract employees in violation of the Procurement Integrity Act. See FAR 3.104. Furthermore, the contractor shall not employ any Department of Defense employee, either military or civilian, unless such person seeks and receives approval IAW Department of Defense 5500.7-R, Joint Ethics Regulation.”

2.1.6. Military Personnel. The contractor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station (PCS), change in duty hours, or deployment.

Military Reservists and National Guard members may be subject to recall to active duty. Abrupt absence of these personnel could adversely affect contractor’s ability to perform; however, their absence at any time shall not constitute an excuse for non-performance under this contract.

2.2. QUALITY CONTROL. The contractor shall utilize its existing quality control program to ensure the services are performed IAW commonly accepted commercial practices. The contractor shall develop and implement procedures to identify, prevent and ensure non-recurrence of defective services. At a minimum, the contractor shall develop quality control procedures addressing the areas identified in Section 2, Services Summary.

2.3. QUALITY ASSURANCE. The Government will evaluate the contractor’s performance IAW the Quality Assurance Surveillance Plan (QASP) by appointing a GR to monitor performance to ensure services are received.

2.4. GOVERNMENT REMEDIES. The KO shall follow FAR 52.212-4, Contract Terms and Conditions- Commercial Items, for the contractor’s failure to perform satisfactory services or failure to correct non-conforming services.

2.5. CONTRACTING OFFICER (KO) AUTHORITY. Only the KO has authority to enter into, administer, terminate or modify the terms and conditions herein. Any changes made by persons other than the KO will be considered an unauthorized commitment and subject to ratification actions IAW FAR 1.602- 3.

2.6. GOVERNMENT REPRESENTATIVE (GR). The contractor shall coordinate all aspects of this requirement with the GR. Completed work shall be subject to inspection and acceptance by GR. This designation will be made in writing by the KO at the time of contract award, or prior to commencement of GR duty. The GR shall NOT direct or redirect any contractor action(s). This can only be done by the KO.

Mrs. Caitlin N. West, Lab Chief, USAMEDDAC-J Phone: 046-407-4886

SSG Eric B. Blue, Lab NCOIC, USAMEDDAC-J Phone: 046-407-4775

Mr. Masanori Kitazume, Medical Technologist, USAMEDDAC-J Phone: 046-407-5472

Mr. Hisashi Inoue, Medical Technologist, USAMEDDAC-J Phone: 046-407-5472

SSG Silvia P. Zuniga, Biomed Maintenance NCOIC, USAMEDDAC-JAPAN Phone: 046-407-4339

Mr. Takeaki Matsuda, Purchasing & Contract Assist, USAMEDDAC-J Phone: 046-407-5577

All can be reached by FAX at 046-407-5308

2.7. AVAILABILITY OF FACILITY.

Hours of Service. The contractor’s personnel will perform scheduled work on weekdays, Monday through Friday (exclusive of the U.S. legal and other designated holidays listed below), during normal duty hours, 0800 - 1630 hours unless prior arrangements have been made with the GR.

Legal American Holidays and Other Designated Holidays.

American Holidays 1 January New Year’s Days 3rd Monday in January Martin Luther King Jr.’s Birthday 3rd Monday in February President’s Day Last Monday in May Memorial Day 4th of July* Independence Day

1st Monday in September Labor Day 2nd Monday in October Columbus Day 11 November* Veterans Day 4th Thursday in November Thanksgiving Day 25 December* Christmas Day

Other Designated Holidays 11 August Mountain Day 1, 2 & 3 January New Year’s Days 29, 30 & 31 December Year End Days

*Holidays falling on a Saturday will be observed on the preceding Friday, and holidays falling on a

Sunday will be observed on the following Monday.

2.7.1. Arrangements of the Performance Time. Should the contractor decide to perform any of the required services before or after normal duty hours, the contractor shall request approval prior to performance from the GR and shall do so at no additional cost to the Government.

2.8. SECURITY AND SAFETY REQUIREMENTS.

2.8.1. Installation Base Passes. The U.S. Government will issue all required Installation/Base Passes and Controlled Area Badges to contractor personnel at no cost to the contractor. Vehicle insurance certificates are required to obtain Base Passes and must cover the automobile liability insurance in the types and minimum amounts of (a) Bodily Injury - ¥30,000,000 per person per occurrence, in addition to the Japanese Compulsory Insurance (JCI), and (b) Property Damage - ¥3,000,000 per occurrence. The prime contractor shall be responsible for all passes issued to his/her own or subcontractor’s employees under this contract. The contractor shall return all applicable passes upon termination of employment or completion of this contract to the Japanese Pass Section, and a certificate of receipt shall be obtained.

NOTE: Contractor personnel are required to comply with U.S. Army Regulation 190-5 for personnel pass requirements. Contractors are also required to comply with U.S. Army Garrison Japan Regulation 190-13 for vehicle pass requirements. These regulations are available for the selected contractor’s review upon personnel and/or vehicle pass issuance.

2.8.2. Security Requirements. The contractor shall ensure each employee obtains all the required passes and identification items for access to U.S. Government’s installations. These items are issued by the Security Forces Pass and Registration Section. The contractor and employees shall return identification cards to Security Forces within 24 hours of termination or completion of this contract. All other Government identification for terminated employees shall be returned to the KO within 24 hours of termination.

2.8.3. Off Limit Signs. The contractor shall provide warning and/or ”OFF LIMITS” signs in both English and Japanese and post them at the entrances of jobsite, and barricades around the jobsite while the equipment and/or systems are being serviced. The contractor shall control all personnel desiring access into jobsite areas when work is in progress.

2.8.4. Photography Permission. The contractor shall obtain GR approval prior to commencing any photography.

2.8.5. Reports of Damages, Destruction, Injury, or Death.

2.8.5.1. The contractor shall report all incidents of damage or destruction to property, or personal injury or death to any person, arising out of and during the performance of this contract. The term “property” includes equipment, freight, or property of any type, whether Government owned or not. The term “contractor” includes the contractor, its agents, servants or employees.

2.8.5.2. The contractor shall submit these reports to the KO through the GR as follows:

(a) A preliminary report shall be made as soon as practicable after the time the incident occurs. The report may be either verbal or facsimile.

(b) A complete written report shall be submitted within 4 days (96 hours) after occurrence of the incident. A copy of this report shall be furnished to the GR.

2.8.6. Security Danger Warning, Accident Prevention, Fire Prevention and Fire Protection Requirements. The contractor shall comply with all pertinent requirements of the U.S. Army and USAG-J Fire Protection and Safety Regulations or Laws of Japan, whichever is more stringent, to insure compliance by all subcontractors.

2.8.7. Environmental Regulations. The contractor shall comply with all U.S. Government and Japanese environmental laws (Japan Environmental Governing Standards), whichever are most stringent, to protect the health and safety of employees/residents, and preserve the local and global environment.

2.8.8. Delivery and Storage of Materials. All materials delivered and placed in storage shall be protected from the weather, humidity and temperature variations, dirt and dust, or other contaminants by the contractor.

2.8.9. Disposal of Materials. All debris and unserviceable materials generated under this contract such as industrial waste, non-recyclable materials and equipment/material not listed on hand-receipts shall be disposed of off-base by the contractor IAW the laws of Japan. Hand receipt items require turn-in action by the contractor when the listed items have to be replaced.

2.8.10. Responsibility for Damages. Any damages caused to U.S. Government property during the course of performing this contract shall be restored, replaced and/or repaired to its original condition at no additional cost to the U.S. Government.

2.8.11. Temporary Work Stoppage. In the event the Garrison Commander requests a temporary shutdown of the facility, the contractor will be notified in writing by the KO. Any Government caused delays as a result of a temporary shutdown that may require an adjustment to the contract will be coordinated through the KO.

2.9. CLEANLINESS. The contractor is responsible for cleanliness of the service areas. This includes, but is not limited to, washing, sweeping, dusting and other janitorial services necessary to maintain the area in a clean and sanitary condition. The contractor shall furnish such supplies as required.

2.10. COMMERCIAL WARRANTY. The contractor shall provide the Government with their commercial warranty. The Government shall receive the same warranty service as the contractor’s most favored customers. If the services fail to be performed or otherwise fail due to workmanship or materials, the contractor shall correct the affected area(s) at no additional cost to the U.S. Government. The Government reserves the right to reject any unserviceable or substandard item and to require replacement with a serviceable like item or acceptable quality item or to require full credit for the item.

2.11. CONSERVATION OF UTILITIES. The contractor shall instruct employees in utility conservation practices. The contractor shall be responsible for operating under conditions, which preclude the waste of utilities. The contractor shall comply with additional energy policies upon notification by the KO.

SECTION 2

SERVICE SUMMERY

The following Services Summary (SS) identifies the performance objectives and performance thresholds for critical tasks associated with providing support services for this requirement. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement.

These thresholds are critical to mission success.

- Perform manufacture specific maintenance bi-annually.

- Equipment must be operational and complete its designed function.

Note:

Adjustments to the method of assessment shall remain the unilateral right of the government.

Contractor may not use the method of assessment for any excusable delay.

FA5209

Attachment 1

SECTION 3

APPENDIX A

List of Equipment / INSPECTION, MAINTENANCE AND EXPECTED REPAIR

SERVICE

MODEL DESCRIPTION S/N ECN FREQUENCY

Beckman Coulter UniCel DxH 800

HEMATOLOGY

ANALYZER

AY19253 005075 SEMI-ANNUAL

Notes

1) Immediately notify GR if there is an issue with equipment.

2) There will be no change of the equipment configuration without the GR approval.

APPENDIX B

UniCel DxH 800 Coulter Cellular Analysis System Specifications.

Available Test Menu

CBC WBC, UWBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

Differential NE, LY, MO, EO, BA, NRBC, NE#, LY#, MO#, BA#, NRBC# Retic RET, RET#, MRV, IRF Body Fluids (Spinal, Serous and Synovial) TNC, RBC

Throughput Up to 100 samples/hr Aspiration Volumes

Open/Closed Vial 165μL Power 100-264 VAC and 48-62 HZ DxH 800 System with System Manager and printer draws 1,185 watts DxH 800 System with System Manager, printer and UPS draws 2,390 watts

Weight and Dimensions Depth Width Height Weight Specimen Processing Module 78.7cm 76.2cm 96.5cm ~117.5kg Pneumatic Supply 51.0cm 21.6cm 36.8cm ~18.4kg Optional Floor Stand 78.7cm 76.2cm 83.8cm ~125.6kg

Whole Blood Performance – Measuring Range

WBC 0.000 – 400.000 X 10(3) μL

RBC 0.000 – 8.500 X 10(6) μL HGB 0.00 – 25.50 g/dL MCV 50.00 – 150.00 fL

PLT 0.0 – 3,000.0 X 10(3) μL

NRBC 0.00 – 600.00/100 WBC

Retic 0.000 – 30.000 %

Data Management Computer Microsoft* Windows* XP Database 40,000 patient results with graphics Quality Assurance QC with Lavey-Jennings Graph, XB/XM for moving Averages, Daily Check, Intelligent Quality Monitoring

Sample Transport Capabilities Capacity 20 five-tube cassettes Bar Codes Digital Bar Code with 2D Bar Code capability Sample ID Up to 22 character

APPENDIX C

(1). Operating Manual, IFU (Instruction for Use):

https://www.beckmancoulter.com/en/search?query=*&index=0&size=25&languages=English&type=tec h-docs&categories=Instrument%20IFU&subcategories=&productlines=Hematology&productseries=UniC el%20DxH&products=

(2). Field Service Training Certificate issued by Beckman Coulter K.K.

(*Note: the appendix is accompanied separately)