Attachment_1_-_PWS_FA527018QB004.pdf

RFQ No: FA527018QB004

PERFORMANCE WORK STATEMENT

FOR

RENTAL AND SERVICE

OF

HEMATOLOGY ANALYZER

AT

KADENA AB, OKINAWA, JAPAN

18 MDSS/SGSL

Kadena AB, Okinawa, Japan 30 Nov 2017

PERFORMANCE WORK STATEMENT

TABLE OF CONTENTS

Number Paragraph Title

Page

Section I – Description of Services

1.1 General Scope 4

1.2 Rental Equipment 4

1.3 Maintenance Services 5

1.4 Work Performance 6

1.5 Emergency Repairs 6

1.6 Repairs Service Calls 6

1.7 Service Not Included 7

1.8 Purchase the Supply for Hematology Analyzer 7

Section II – Service Delivery Schedule

2.1 Service Delivery Summary 8

Section III – Government-Furnished Property and Services

3.1 Government-Furnished Property and Service 9

Section IV – General Information

4.1 Quality Control Inspector (QCI) 9

4.2 Security Requirements 9

4.3 Workday/Hours of Operation 11

4.4 Period of Performance 11

4.5 Contract Personnel 11

4.6 Contractor’s Failure to Perform 11

4.7 Submission of the Report for Maintenance and Repair 12

4.8 Invoice 12

4.9 Work Area Layouts 12

4.10 Performance of Services during Crisis Declared by the National 13 Command Authority or Overseas Combatant Commander

Section V – Appendix

Appendix A – List of Reagents 13

SECTION I.

DESCRIPTION OF SERVICES

1.1. GENERAL SCOPE: The contractor shall provide all management, tools, supplies, replacement parts, equipment, and labor necessary to perform the service maintenance and repair for the rental hematology analyzer. The contractor will also provide all the reagents and controls for the hematology analyzer at 18th MDG Laboratory, Bldg. 626, room LK08.

1.2. RENTAL EQUIPMENT:

1.2.1. The contractor shall provide the hematology analyzer and services. The hematology analyzer shall be Food and Drug Administration (FDA) cleared, contain the autoloader feature, and offers both standard and pediatric tube capabilities using auto and manual mode utilizing a single aspiration pathway. The analyzer shall have a closed collection tube sampling with batch interrupt for stat sample processing. The hematology analyzer must have the ability to perform 5-part cell automated differential, WBC differential histogram plots, abnormal WBC morphology identification flags, and nucleated RBC identification. The analyzer must be protected from and suppress electrical signal interference during laboratory use, shall utilize a unique item identifier, printing capability, and sample identification achieved by barcode and manual input (Coda bar 39, Codabar, Codabar 128, ISBT 128). The contractor shall provide a vendor-sponsored training off-site or on-site to the 18th MDG Laboratory testing personnel before the analyzer can be used for patient testing.

1.2.2. Instrument Installation: Installation shall conform to Industry Standards and shall meet or exceed with all applicable codes to include Local/State Regulations, NFPA, building codes, communications codes, and other codes for each utility identified. The contractor shall be responsible for instrument installation, set-up, initial calibration and method comparison study as specified by the manufacturer, Clinical Laboratory Standards Institute (CLSI), and the College of American Pathologists (CAP) regulatory requirements.

1.2.3. Performance Characteristics: The contractor shall perform an initial validation and method performance studies to include, but not limited to method correlation study, reproducibility and carry-over study, linearity, sample stability testing, reference range validation, and analytical interfering substance evaluation in accordance with CLSI and CAP accreditation requirements.

1.2.4. A written report, in English format, on the initial method validation and performance of the instrument shall be provided to the laboratory and must be approved by the 18th MDG Laboratory Director or designee before the analyzer can be used for patient testing. Precision reports shall be reported in standard deviation (SD) and coefficient of variation (CV) as required by the CAP and CLSI.

1.2.5. Quality control (QC) materials must be a commercially assayed. QC data shall have plotting capability, moving averages, daily check, out-of-range QC result verification and alarm, and peer comparison venue with labs that use similar instruments and methodology. The clinical hematology analyzer should have visual and audible alarms that flag abnormal QC and patient results.

1.2.6. Reagents, controls, calibrators, and supplies shall have expiration dates, and shipping and storage temperature ranges within allowable limits for cold and hot storage. Safety Data Sheets (SDS) shall be readily available electronically at no additional charge. Delivery option shall be in accordance with the Performance Work Statement.

1.2.7. Manufacturer shall provide regular and on-time software updates. The analyzer shall have an operating and data management system compatible with the Department of Defense Composite Health Care System (CHCS). If the 18th MDG receives a notification for a device alert or recall which affects this system, the manufacturer will cover the cost for all required parts or component replacement, any software upgrades and any associated labor cost to resolve the device alert.

1.2.8. The hematology analyzer is considered to be in good serviceable condition if it is performing all its intended functions and there are no missing or broken parts. Also it shall not be rejected on the basis that it needs cleaning, minor repairing, or adjustments.

1.2.9. The contractor shall maintain ownership of the hematology analyzer and is responsible for all maintenance and repairs while in the possession of the 18th MDG. The contractor is responsible for the disposal, removal, and shipping costs of the clinical hematology analyzer at the end of the contract period or at the government’s discretion.

1.2.10. Installation, demonstration, and operation training for the hematology analyzer will be provided to the 18th MDG Laboratory personnel at no additional charge. The contractor shall provide training for all the intended users and evaluators. Training should include principles of methods of measurement, operation, quality control, calibration, maintenance of the instrument, and troubleshooting as stated in the analyzer’s Technical Manual. Instruction manual (electronic and hardcopy) shall be readily available and assessed for quality and completeness. The contractor is responsible for any damages incurred while installing/uninstalling and when performing maintenance on the clinical hematology analyzer.

1.3. MAINTENANCE SERVICES: The contractor shall provide in writing the schedule for routine preventive maintenance (PM) and service on all covered equipment. PM schedule shall be coordinated with the 18th MDG Laboratory personnel and shall limit patient care interruptions as much as possible. PM shall be performed as required by the manufacturer’s instruction manual, analyzer specifications, CLSI and CAP regulatory standards. PM shall be conducted in the18th MDG Laboratory, bldg. 626, room LK08. Service and Operator Manuals shall be included. Service and Technical Support shall be available by phone with English speaking technicians 24 hours a day, seven days a week.

1.3.1. The contractor shall provide qualified, certified technicians, test equipment, tools and material to perform troubleshooting, repair, preventive maintenance, software upgrades, firmware upgrades, calibration, operational checks, and adjustments to on-site equipment in order to ensure the equipment is fully operational and within manufacturer specifications.

The contractor shall provide the option of on-site manufacturer assisted calibration and linearity verification.

1.3.2. The contractor shall provide for full parts, labor, and service-person travel expenses. The contractor shall prepare and submit a written report (hardcopy or electronic), in English, within three business days of the maintenance or repair to the assigned Government representative.

1.4. WORK PERFORMANCE: Work performed shall consist of all service calls required during the term of the contract. Work performed shall be in accordance with manufacture’s commercial practice and shall include, but not be limited to keeping the machine and computer operating system in good operating and serviceable condition.

1.4.1. The contractor shall systematically service the equipment covered by this contract within the allotted time set forth for each periodic service. Service shall include necessary cleaning, oiling, adjusting, calibrating, replacing parts and accomplishing minor and major repairs. Minor and major repairs are those repairs that can be accomplished on site utilizing normal portable tools and equipment applicable to the trade. Suggestions for improvement and efficiency of operation should be offered by the contractor to operator at the time services are made. The contractor shall cover regular software updates and ensure software is compatible with CHCS and meets Department of Defense security software requirements.

1.4.2. The contractor shall prepare and submit a written report (hardcopy or electronic), in English, within three business days of the maintenance or repair to the assigned Government representative.

The report shall identify the name of equipment, date of maintenance, part number of equipment, location, corrective action and reason of maintenance, name of inspector, and overall condition of the analyzer.

1.4.3. The contractor will include the laboratory in its contact list for analyzer upgrades, urgent safety recall notifications, and technical updates.

1.5. EMERGENCY REPAIRS: Emergency repair shall be available during normal duty hours, 0730-1630, from Monday through Friday, except the holidays (see para 4.4), at no additional charge to the Government. In the event of an emergency, the Government personnel shall notify the contractor.

The contractor shall respond by telephone within 2 business hours of notification for any instrument errors, and be available for on-site repairs within 24 business hours after the Government’s notification for emergency repair calls.

1.6. REPAIRS SERVICE CALLS.

1.6.1. ROUTINE CALLS: The Government personnel will notify the contractor of repairs to be made from the inspection report or service call. The contractor shall report to the work location, survey the repair, and provide to base contracting an estimated time to repair and cost of repairs not covered in the basic service contract. The contractor shall commence repair work after notification from the government personnel within 48 business hours. All repair work shall be in accordance with normal commercial practices using parts specified by the analyzer manufacturer items of equal or better quality. If, for any reason, the contractor is unable to carry out the repairs, the contractor shall make diligent efforts to keep downtime of the hematology analyzer to an absolute minimum without significantly affecting patient care. The contractor must notify the Government representative or 18th MDG Laboratory of all projected downtime and estimated time for repair. The contractor shall prepare and submit a written report in English within three business days after the routine repairs are completed.

1.6.2. EMERGENCY CALLS: The contractor shall respond to emergency repair call within 2 business hours after notification during normal business hours. For non-normal business hours, the contractor shall respond to emergency repair call within 24 business hours after notification.

The contractor shall contact the 18th MDG Laboratory during business hours and the On-Call Lab Tech during non-business hours. The contractor shall prepare and submit a written report within three business days after the emergency repair.

1.7. SERVICE NOT INCLUDED.

1.7.1. The following services are NOT included in this contract:

1.7.2. Installation, maintenance or service of any third party computer system or interface, water supplies, power supplies, plumbing hardware or other OEM accessory; supplies or consumable items including, without limitation, printer supplies, bar code labels, capette dilutors, slides, stain, methanol, piercing needles, or cubetainer spout kits.

1.8. PURCHASE THE SUPPLY FOR HEMATOLOGY ANALYZER: The Cost per Reportable Result (CPRR) will cover all reagents and controls as listed in Appendix A for the terms of this contract.

1.8.1. The contractor will provide and ship reagents and controls based on the monthly average test volume that the 18th MDG laboratory submits to the contractor directly to the 18th MDG laboratory at Bldg 626, Rm LK08 on Kadena AB.

1.8.2. The CPRR rate is based on the 18th MDG Laboratory estimated annual test volume. The contractor, with advice from the 18th MDG Laboratory, will perform periodic reviews of reported test volumes. The contractor will adjust the CPRR rate accordingly at the annual renewal date of the contract.

1.8.3. The contractor prepares the delivery ticket of the reagents supply. It must include the contract number, delivery date, item description, quantity, unit price and total amount.

Contractor shall not provide reagents that will expire within six months from delivery date. It must be dated and signed by a representative of the 18th MDG Laboratory, bldg. 626, room LK08. A copy will be given to Medical Logistics Flight in Bldg. 626, Room # BA36.

SECTION II.

SERVICE DELIVERY

SCHEDULE

2.1. SERVICE DELIVERY SUMMARY.

Performance Objective Performance Threshold

Perform the preventive maintenance (Paragraph 1.3, 1.3.1, 1.3.2)

As required by analyzer manual and specs, CLSI, and CAP

Repair service calls (Para. 1.6) The Contractor shall communicate all projected downtime and estimated repair time.

Emergency Repairs (Para.1.5 and 1.6.2) Response within 2 business hours during normal business hours or within 24 business hours for non-normal business hours.

Submit maintenance and repair reports (Para.

1.3.2, 1.4.2, 1.6.2 and 4.7)

Accurate reports are delivered within three business days.

Deliver the reagents supply (Para. 1.8.3) The contractor shall deliver the supply to 18th MDG Laboratory, Rm LK08. based on monthly reported test volume.

SECTION III.

GOVERNMENT-FURNISHED PROPERTY AND SERVICES

3.1. GOVERNMENT-FURNISHED PROPERTY AND SERVICES: Government-

Furnished Property and Services does not apply to this requirement.

SECTION IV.

GENERAL INFORMATION

4.1. QUALITY CONTROL INSPECTORS (QCI): The QCI is hereby designated to participate in the administration of this contract to insure that contractor’s compliance with its technical requirements, including inspection and acceptance of the service for the government at the performance sites. The QCI for this maintenance agreement is the NCOIC of Clinical Engineering, at the Biomedical Equipment Repair telephone extension 630-4864.

4.2. SECURITY REQUIREMENTS: Security requirements will include but not be limited to base pass requirements, security clearance requirements, Medical Treatment Facility (MTF) required common access card training and will be processed through the Air Force. The MTF unit security monitor will initiate a DD Form 254, DOD Contract Security Classification Specification, if security requirements are in effect. The contractor is responsible to obtain security requirements from the awarded task order site’s security personnel and ensure they comply. Detailed security requirements will be defined at the task order level.

4.2.1. Pass and Identification Requirements: Each employee will obtain the required pass and identification items as applicable for contractor personnel and contractor owned vehicles. The contracting office shall provide base access to approved contracting employees.

4.2.2. Listing of Employees: The contractor shall maintain a current listing of employees. The list will include employee names and identification information. This list will be validated by the contractor and provided to the Contracting Officer’s Representative (COR) and Air Force Medical Support

Agency, Health Facilities Division (AFMSA/SG8F SRM) within 5 calendar days of start of period of performance of the contract or option year. An updated listing shall be provided upon any change of employees at the task order level.

4.2.3. Security Training: The contractor and all associated sub-contractors shall receive a brief/training (provided by the MTF) on the local suspicious activity reporting program. This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the project manager, security representative or law enforcement entity. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR no later than 5 calendar days after the completion of the training. All contractor employees and associated sub-contractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Air Force training requirements in DoD 8570.01, DoD 8570.01-M and AR 25-2 within one month of employment.

4.2.4. Escorting of Employees: All contract employees, including subcontractor employees who are not in possession of the appropriate security clearance or access privileges, will be escorted in areas where they may be exposed to classified and/or sensitive materials and/or sensitive or restricted areas.

4.2.5. Employee Training: Contractor employees are required to attend mandatory MTF-provided in-service training (e.g., Newcomer’s Orientation, Infection Control, Blood-borne Pathogens, etc.). Completion of MTF-provided training should be documented and a copy of the documentation provided to the contractor for the employee’s personnel record. Completion of training/ certifications shall be reported to COR within 3 days of completion and within 15 days of start of period of performance as applicable.

4.3. WORKDAY / HOURS OF OPERATION: A workday shall be construed as the normal eight hours, 0730-1630, workday of the using activity within a work week, Monday through Friday, except holidays observed at the Government installation. Holidays are as follows:

1 January New Year’s Day* Third Monday of January Martin Luther King Jr. Birthday Third Monday of February President’s Day Last Monday of May Memorial Day 4 July Independence Day* First Monday of September Labor Day Second Monday of October Columbus Day 11 November Veterans Day* Fourth Thursday Thanksgiving day 25 December Christmas Day *If holiday falls on a Saturday, it will be observed on the preceding Friday. If it falls on a Sunday, it will be observed on the following Monday.

4.4. PERFORMANCE PERIOD:

FY18 Base Year: 15 Apr 18 – 14 Apr 19 FY19 Option Year 1: 15 Apr 19 – 14 Apr 20 FY20 Option Year 2: 15 Apr 20 – 14 Apr 21

4.5. CONTRACT PERSONNEL: The contractor shall provide a contract supervisor; dedicate to this contract during performance of required services. The contract supervisor must able to read, write, speak and understand English.

4.6. CONTRACTOR’S FAILURE TO PERFORM.

4.6.1. Contractor fails to perform required services within the specific limitations, the government may,

4.6.1.1. Accept the services at a later date, or

4.6.1.2. Refuse to accept the services at a later date (in which case the government will bear no cost and make no payment for the missed service), or

4.6.1.3. Procure the missed service, upon such terms and conditions as the Contracting Officer deems appropriate, from an alternate, responsible firm and the contractor shall be liable to the government for any excess costs incurred and to continue the performance as required thereafter.

4.7. SUBMISSION OF THE REPORT FOR MAINTENANCE AND REPAIR.

4.7.1. The report must be prepared to verify the performance of maintenance/service calls.

4.7.2. The report shall be delivered to 18th MDG within three business days.

4.7.3. The report must include the name of the person who performed the services, repairs made to the item, maintenance or services, dated and signed, parts replaced, reason for maintenance and repair, calibration and quality control results. It must be dated and signed by a representative of the 18th MDG Clinic Laboratory in Bldg 626, Room # LK08. A copy will then be given to Medical Logistics Flight in Bldg 626.

4.8. INVOICE.

4.8.1. The contractor shall submit the invoices for rental equipment and purchased dry reagent to 18th MDG Logistics Flight, Bldg. 626, room BA36.

4.8.2. The contractor shall submit the invoices by the 7th day of each month for the preceding month’s charges.

4.8.3. The billing period shall be started on 1st day of the month and closed at end of the month.

4.8.4. The contractor’s invoice shall show:

4.8.4.1. Contract Number

4.8.4.2. Billing Period

4.8.4.3. Item description, unit price, quantity and total price

4.8.4.4. Amount of the service/purchase

4.8.4.5. Make, model and serial number of machine

4.8.4.6. Invoices (3 copies) shall be submitted to using activity for certification.

4.9. WORK AREA LAYOUTS.

4.9.1. SET POINT: The contractor shall set the hematology analyzer at the18th MDG Clinic Lab for Bldg 626, Room # LK08.

4.10. PERFORMANCE OF SERVICES DURING CRISIS DECLARED BY

THE NATIONAL COMMAND AUTHORITY OR OVERSEAS COMBATANT

COMMANDER: This service is determined to be non-essential for performance during crisis according to DODI 3020.41. In the event of crisis, the contractor will be notified by the Contracting Officer of the need to discontinue services due to contingency, base closure or other causes. If notification to discontinue services is not received, the contractor shall continue the service to the government in accordance with this Performance Work Statement.

SECTION V.

APPENDIX

APPENDIX A

List of Reagents

Part/Item Number Description Quantity (1 Year)

628017 COULTER® DxH Diluent (10L) 59

628018 COULTER® DxH Cell Lyse (1L) 14

628020 COULTER® DxH Diff Pack 6

628023 COULTER® DxH Cleaner (10L) 11

628027 COULTER® 6C Cell Control (12x) 12

628024 COULTER® LATRON™ CP-X (8x) 12

628026 COULTER® S-CAL® Calibrator 2