Performance Work Statement.pdf

Performance Work Statement

HEMATOLOGY ANALYZER SUPPLIES

341st MEDICAL GROUP

MALMSTROM AIR FORCE BASE, MONTANA

24 April 2025

1398391922C Underline

PERFORMANCE WORK STATEMENT

HEMATOLOGY ANALYZER

1. NON-PERSONAL SERVICES: The contractor shall provide to the government all necessary materials, accessories and reagents to conduct hematology testing on a cost per test/per result basis. The contractor shall furnish all labor, tools, and preventive parts, materials, equipment, qualified personnel, administrative support, reagents, controls, calibrators, and transportation necessary to perform the services for the hematology analyzer, as part of cost per test lease agreement. It shall include all systems, subsystems components, and assemblies. All subsequent maintenance provisions shall apply to hardware, firmware, and software as appropriate, unless otherwise stated.

1.1. DESCRIPTION OF SERVICE:

Service Coverage: Service coverage is provided 24 hours seven days a week, or as needed.

Include unlimited parts, travel and labor. Loaner coverage and unlimited 24 hours telephone support provided. Manufacturer must be able to provide 24 hour “live” telephone troubleshooting and personnel dispatch. Contractor must be factory trained and certified to perform repairs and maintenance on the Hematology analyzer. Contractor must provide proof of training if requested.

1.2. TERMS OF CONDITIONS:

1.2.1. Equipment to be maintained per original equipment manufacturers (OEM) recommendations. Contractor to supply full service preventive maintenance with unlimited service calls as required during normal business hours, Monday through Friday between 0730 – 1630 (7:30 AM – 4:30 PM) CST except for federal government holidays.

1.2.2. Preventive Maintenance Services: Service contractor shall perform preventive maintenance inspections as specified by the manufacturer for those model instruments at the frequencies and intervals specified in this agreement. Preventive maintenance will include, were applicable, inspection and repair of the sampling section, electronics system, pneumatic system, and vacuum system of the instrument. Worn or defective components will be replaced at no charge to the customer. A complete systems check will be performed on the instrument to ensure it is performing to factory acceptance standards. Preventive maintenance services will be scheduled and performed Monday-Friday, 0730 hours to 1630 hours with minimal impact to patient care requirements.

1.2.3. Engineering Changes: All engineering changes issued by the manufacturer or designated by the manufacturer during the term of this agreement which affect the safety or efficiency will be implemented by the service contractor on the next scheduled service call at no charge. All other changes will be implemented subject to the terms of the maintenance agreement.

1.2.4. Loan Instruments: The service contractor shall furnish a loan instrument (must be of the same make) to the customer whenever the customer’s instrument must be returned to the repair center for service.

1.2.5. Terms: Replacement instruments in the event of non-repairable failure may be added to the agreement schedule of services at any time, provided such instruments meet the service contractor service acceptability standards. Charges for instruments added to this agreement after the commencement date will be at the prevailing service maintenance rates in effect on the date of acceptance and shall be prorated from that day to expiration date of this agreement.

1.2.6. Charges: Maintenance service charges for the instrument named on the schedule of services will begin on the service maintenance agreement effective date and shall remain in effect until the service contract is terminated by the customer or service contractor.

1.2.7. Parts: The service contractor warrants that any parts or other components used in servicing the customer’s instrument or provided the customer by the service contractor shall not be defective in materials or workmanship for 90 days. All parts are new or functionally equivalent to new. When service contractor warrants that an instrument under this agreement contains a part not furnished for the instrument by the service contractor or the instrument manufacturer which is particularly significant to service contractor’s ability to provide maintenance service for such instrument under this agreement, service contractor may withdraw the instrument from this agreement upon thirty days written notice to the customer.

1.2.8. Reagents, controls, and calibrators: All reagents required for the operation of the instrument, (at a historical amount of approximately 1721 reagents annually) shall be shipped either when order placed or on a quarterly basis (standing order option must be offered) to arrive within seven days. Reagent shipments shall have at least a 6 month out dating when received and arrive in good working condition. All control and calibration materials shall be shipped either when order placed or on a quarterly/biannual basis (Standing order option must be offered) to arrive within three days. Control and calibration material shipments shall have an expiration date of no less than forty (40) days and arrive in good working condition. All supplied items are to be certified for use within the instrument. Reagents other than controls and calibrators must be viable after thawing should they inadvertently freeze due to environmental conditions in the shipping process. Contractor to warrant that all supply items are free of manufacture’s defects and will repair / replace any unsatisfactory items at contractor’s expense.

1.2.9. Quality Control (QC) program: QC program shall include automatic download of data, statistical summary of QC, Quality Assurance, automatic validation of QC data (flagging of high/low), storage of multiple lot numbers of QC material, Levey-Jennings graphs, and offer an Inter-laboratory Quality Assurance Program (IQAP) to provide peer group assessment of downloadable QC data.

1.2.10. Installation and training: Installation and implementation shall include contractor performed calibration, precision, accuracy, mode-to-mode studies and data stream verifications to ensure successful implementation and to meet the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) requirements. Contractor shall make four training slots available for customer staff over a 5-year period. Minimum of one training slot shall consist of off-site, expense paid training, and a minimum of 2 training slots shall include on-site post installation training.

1.2.11. All items received are to be approved for use (where applicable) in U.S. based medical treatment facilities.

2. MAINTENANCE: Maintenance inspection shall consist of inspection, disassembly, adjustment, replacement of worn/defective parts, reassembly, and calibration of the system (if needed). The instrument shall be maintained to meet the original equipment manufacturer’s specifications and applicable federal, state and local laws and regulations. The instrument shall be maintained in such a manner as to provide a minimum of 99% operational time. Contractor to provide the government with maintenance history within 5 business days of request.

3. SERVICE CALLS: The contractor shall respond to service call requests within two hours by telephone, and service personnel shall be on site within 12 hours, or the next business day. In no case shall the contractor allow the equipment to remain inoperative for more than 72 hours.

4. PREVENTIVE MAINTENANCE: The contractor shall provide one preventive maintenance visit every six month period for the instrument which shall consist of the action stated above to the extent required to maintain the system in operational condition in accordance with the manufacturer’s specifications. Preventive maintenance inspections shall be scheduled and coordinated with the laboratory and Biomedical Equipment Maintenance section (BMET).

4.1. The contractor shall notify the Laboratory and BMET section in person or by telephone at least two weeks prior to the preventive maintenance service visit. The contractor shall sign in with the BMET section in person or notify by phone prior to performing the preventive maintenance service on the day the service is performed. Upon completion of the service visit, the contractor shall furnish a signed copy of service reports explaining all action performed to the Laboratory and BMET section prior to departing from the visit.

4.2. Workmanship shall be subject to inspection, test, and acceptance by the Laboratory and BMET section. In the event that the system calibration is performed, the contractor shall provide documentation stating the tolerance and specifications to which the equipment was calibrated, and the final calibration results.

4.3. The event the instrument is deemed by the contractor to be unserviceable on site, the contractor shall provide a loaner component or instrument for the period that the instrument is removed from service. All shipping costs shall be borne by the contractor. As part of the loaner installation process, contractor will complete an instrument validation to meet CAP and CLIA requirements.

4.4. Mandatory equipment modifications specified by the equipment manufacturer shall be conducted by the contractor after approval by BMET. A copy of all documentation (i.e. work orders, schematics, diagrams, repair parts list, etc.) pertaining or describing the modification shall be provided to the BMET.

4.5. Engineering Changes: All engineering changes issued by the manufacturer or designated by the manufacturer during the term of this agreement which affect the safety or efficiency will be implemented by the service contractor on the next scheduled service call at no charge. All other changes will be implemented subject to the terms of the cost per test agreement.

4.6. Comprehensive Upgrade: Include verification of the instrument on each service call, maintenance consumables, glassware and plasticware coverage, and power analysis support to include uninterrupted power supply (UPS).

5. AT REQUIREMENTS: In accordance with DoDI O-2000.16-V1_DAFI 31-145-O, Antiterrorism (AT) Program Implementation, Level I – AT Awareness Training shall be completed by all contractor personnel within 30 days of requiring access, and annually thereafter. The training will be provided by the government. The objective of the training is to provide personnel with requisite knowledge necessary to remain vigilant and enable employment of AT tactics, techniques, and procedures.

5.1 Contractor personnel are required to abide by all real world Force Protection Condition (FPCON) measures, random anti-terrorism measures (RAMs), shelter -in-place orders, evacuations and lock-down notices as directed. Examples include mandatory badge or ID checks, facility single points-of-entry and searches of hand carried items.

5.2 Any photograph, sketch, picture, drawing, map, or graphical representation of US Government property to include: facilities, aircraft, components, equipment, or other resources is prohibited without first obtaining permission from the government (e.g. Security Forces convoys, Helicopters, Entry Control Points, etc.)