PWS Sysmex XN-450 21 Nov 22.pdf

Performance Work Statement (PWS) – 21 November 2022

1.0. Description of Services/General Information (definitions, etc). The contractor shall provide scheduled preventative maintenance inspections (PMI’s), calibrations, and on-site emergency services for the equipment listed below. Service shall include travel, labor, parts, materials, updates, technical data, and required tools and test equipment. Services shall be performed during normal duty hours of 0730 to 1630, Monday thru Friday. Response time shall not exceed 24 continuous clock hours.

1.0.1. Description: Analyzer, Laboratory, Hematology Analyzer System Sysmex XN-450

Model: XN-450 Manufacturer: Sysmex Corporation of America Location: Building 2114 Room: Laboratory, Rm, 172, 86 Medical Group, Ramstein AB

1.1. Required Services:

1.1.1. Preventative Maintenance Inspections (PMI’s). These inspections will include quality assurance checks for proper operation, detection and correction of incipient failures, actions pertaining to periodic technical inspections, lubrications, adjustments, calibrations, controls, cleaning, and replacement of worn parts.

(a) Two (2) PMIs shall be performed biannually (6-months) per contract year.

1.1.2. PMI’s should include:

(a) Consulting with equipment operators regarding equipment performance

(b) Performing operational checks on all systems and correcting noted deficiencies

(c) Replacing worn or defective parts (those parts that may fail before the next PMI)

(d) Cleaning and lubricating IAW manufacturer’s service manual.

(e) 6-month calibration of analytes IAW College of American Pathologists (CAP) standards.

(f) All services include associated travel expenses, associated labor costs, needed cleaning, control, and calibration material.

1.1.1.3. Scheduled PMI’s shall be coordinated with the Ramstein Laboratory Clinic at least one week in advance.

1.1.1.4. Emergency Service Calls. On site emergency service is the repair necessary to return the system to its intended functional state of operation. The contractor will provide on-site repair to correct all malfunctions that occur. The service technician will continue uninterrupted service until the system is operational according to manufacturer’s specifications. Travel and overtime will be included at no additional cost. All tools, test equipment, parts, and supplies will be the responsibility of the contractor.

(a) Response time to emergency service requests shall not exceed 48 continuous clock hours, excluding weekends and holidays. If technician does perform work on the instrument during weekends and holidays, we will only compensate for the cost of labor.

(b) The equipment shall be repaired within 24 continuous clock hours after arrival to the equipment site, excluding German holidays. The need for unavailable parts will suspend the time limit until parts are obtained. These parts shall be obtained in the swiftest manner at no additional cost to the government.

(c) Use of the Sysmex Hotline. The hotline should be available for questions/concerns and troubleshooting advice from the hours of 8 am to 6:30 pm, Monday thru Thursday and from 8 am to 5:00 pm, Fridays.

1.1.1.5. Equipment Updates. The contractor shall furnish and install all software update and equipment modifications provided by the manufacturer. These updates are provided at no additional cost and installed no later than the next PMI or emergency visit.

1.2. Administrative:

1.2.1. The contractor will receive PMI and on-site emergency service requests from Medical Equipment Repair Center (MERC). Upon arrival, the contractor will contact MERC before performing any work specified in this agreement.

1.2.2. The service technician will prepare a service report for each visit and obtain the signature of a supervisor within the Laboratory or by a COR certifying acceptance of services performed. The report shall be in the English language and describe the service performed in sufficient detail and include the following:

(a) System name, model and serial number, location, and site number if applicable

(b) Purpose of the visit or description of the malfunction

(c) Start/Stop times and dates

(d) Break down of travel and labor hours

(e) Description of all services rendered – including calibration validation & linearity verification data of all analyte parameters including WBCs, RBCs, Platelets, Hemoglobin, and Hematocrit IAW the College of America Pathologists (CAP) evidence of compliance.

(f) Complete list of replacement parts used

(g) Attached copy of test records or checklist used to prove completion of PMI

(h) Signatures of the person performing the service and of the person accepting the service.

1.2.3. The contractor will deliver one copy of the service report to the MERC office located in the Medical Logistics Warehouse from the clinic on Base, building 2497.

1.2.4. Replacement Parts. The contractor shall use only new original or factory refurbished replacement parts. The service personnel should carry or have the manufacturer’s “recommended stock” of parts for the system readily available.

1.2.5. Training/Experience. Service technicians should have received factory training on this or like systems.

Individuals should be actively engaged in repairing like systems for 12 of the last 18 months.

1.2.6. Test Equipment. The contractor shall ensure that all test equipment used has been calibrated according to manufacturer’s specification against a traceable standard

1.2.7. Technical Data. The contractor’s service personnel will maintain a complete file of technical documentation for the system serviced to include schematics, service manuals, update memos, and service history records.

1.3. Performance-Based Check:

1.3.1. The Contractor shall perform work under this contract consistent with the relevant environmental policy and objectives identified in the installation environmental management system (EMS) applicable for your contract. The Contractor shall perform work in a manner that conserves water, energy and other resources to the maximum extent feasible and ensure minimum production of waste as possible, giving preference to recycling and reutilization opportunities. Furthermore, the Contractor shall give preference to less toxic materials whenever available and still reliable for their work. In the event an environmental nonconformance or noncompliance of host nation and USAF environmental laws and regulations associated with the contracted services is identified, the contractor shall take corrective and/or preventative actions. In the case of a noncompliance, the Contractor shall respond and take corrective action immediately. In the case of a nonconformance, the Contractor shall respond and take corrective action based on the time schedule established by the EMS Coordinator. In addition, the Contractor shall ensure that their employees are aware of the environmental management system on base and how these requirements affect their work performed under this contract.

1.3.2. Conformance with Environmental Requirements. The contractor shall perform all work in accordance with applicable German and US Air Force environmental laws, regulations and operating standards, including but not limited to the Final Governing Standards (FGS) for Germany. The contractor shall be immediately capable of understanding and addressing environmental laws and regulations as they pertain to work performed under this contract.

1.4. Contracting Officers Representative:

1.4.1 The designated representatives authorized to place calls for this agreement will be the Laboratory, MERC or Contract Services personnel. CORs may be contacted at:

(a) Bldg.: 2114

Laboratory 66877 Ramstein Air Base PH: 06371-46-2577 or 2586

(b) Bldg. 2497

Contract Services /Medical Equipment Repair Center 66877 Ramstein Air Base PH: 06371-46-2430 or 2438

1.5. Consumables

1.5.1. The Laboratory would like to request scheduled deliveries for the following consumables:

Item

Unit

Item‐No.

Packages per year

Delivery Cycle

Cellclean Auto

Package 20 x 4 ml

BQ095093

1 every 17 weeks

XN‐L CHECK LEVEL 1

Box 6 x3 ml

213570

12 weeks

XN‐L CHECK LEVEL 2

213571

XN‐L CHECK LEVEL 3

213572