Attachment 1 - Performance Work Statement dated 23 Mar 26.pdf

Performance Work Statement 23 March 2026

1. SCOPE OF WORK: Equipment Lease/Service program. The contactor shall provide all personnel, equipment, tools, materials, installation reagents, supervision, transportation, one service/operator's manual and other items and services necessary for the installation and operation of the hematology analyzer for 4,500 annual patient tests and ancillary components/equipment at the McConnell AFB Clinic, 57950 Leavenworth Ave, Wichita, Kansas, 67221. The specifications are as follows:

1.1. New (not previously owned) Food & Drug Administration (FDA)-approved analyzer and components, with auto-loading feature.

1.2. Capable of performing at least 75 complete blood counts with 5+-part differential (CBC) per hour.

1.3. The system must fit within an 18” by 26” countertop space.

1.4. Capable of processing adult and pediatric (micro-sample) specimen collection tubes and require no more than 100 uL of whole blood specimen to perform analyses.

1.5. Uses optical and/or laser technology to enumerate and differentiate white blood cells (WBCs): neutrophils, lymphocytes, monocytes, eosinophils, and basophils; and platelets.

1.6. Measures and reports red blood cells (RBCs) with indices: hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), and red blood cell distribution width (RDW).

1.7. Capable of enumerating immature granulocytes and nucleated red blood cells (NRBCs), and detecting/flagging the presence of variant lymphocytes, blast cells, platelet clumps, and giant platelets.

1.8. Be capable of analyzing white blood counts (WBCs) up to 200K/uL with overall 97% precision, and platelets up to 3000K/uL with overall 96% precision.

1.9. Must have on-board tracking of reagent and controls.

1.10. Must provide calibration material.

1.11. Must provide at least three levels of control material.

1.12. Must offer options for user-defined patient parameters.

1.13. Contractor shall only offer items which already have an Authorization to Operate (ATO), or items for which the contractor agrees to go through the DoD Information Assurance (IA) approval process and obtain a Risk Management Framework (RMF) ATO. A completed Joint Medical Device Risk Assessment Questionnaire (DRAQ), vl.1, for the offered system must be provided with proposal.

All equipment and software supplied at initial and subsequent installations will accurately reflect responses provided on DRAQ.

1.14. The system must have barcode/data reading capabilities.

1.15. The system must have proven interface capabilities with Hospital Information System, MHS Genesis.

1.16. Possess software capable of multitasking, i.e., allows technicians to perform data operations simultaneously with analyzer operations.

1.17. Offer peer data solutions for comparison of quality data.

2. OPERATIONAL/SERVICE REQUIREMENTS: Equipment and services must comply with Clinical Laboratory Improvement Act (CLIA), Occupational Safety and Health Administration (OSHA), Centers for Disease Control and Prevention (CDC), and FDA requirements. In addition to analyzer system, the contractor supplies the following at no additional expense to the government:

2.1. All materials, accessories, reagents, calibrators, and ancillary products necessary to operate the analyzer and report results via bi-directional interface on a cost-per-test or cost- per-reportable basis.

2.2. All software and hardware necessary to operate the analyzer and manage integrated software.

2.3. The contractor shall directly provide scheduled preventative maintenance inspections (PMis), calibrations/calibration material, and on-site repair services for all provided equipment. Manufacturer-recommended parts, materials, updates, technical data, tools and test equipment shall be used, as applicable.

2.4. Maintenance Services: Once maintenance actions are initiated, shall be continued through completion unless otherwise coordinated with the laboratory.

Services shall be performed during normal duty hours of 0730 to 1630, Monday thru Friday. The contractor shall provide a service report for any maintenance, inspection, or repair activities performed on site, prior to departing the clinic.

2.4.1. Scheduled Maintenance. The contractor shall coordinate required PMs and system calibrations at least two weeks in advance and will performance scheduled services with minimal disruptions to laboratory operations. These inspections shall 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 at a biannual frequency.

2.4.2. Customer Support. The contractor shall provide telephone customer service for analytical equipment Monday through Friday, 0730-1630 CST, excluding federal holidays. Telephone assistance shall be toll-free to the government for troubleshooting and/or repair support for malfunctions. All tools, test equipment, parts, and supplies necessary to return the equipment to operating specifications will be provided at no additional government expense.

2.4.3. Unscheduled Maintenance. If the analyzer system is not operational, and telephone support fails to resolve the issue, the contractor's representative is to arrive within one business day of the service request. All tools, test equipment, parts, and supplies necessary to return the equipment to operating specifications will be provided at no additional government expense. Unscheduled downtime for non-preventative maintenance/repairs shall not exceed 3% of the total operational time.

3. INSTALLATION

3.1. The contractor shall provide an Uninterrupted Power Supply (UPS) for the analyzer and supporting equipment. The contractor shall ensure that the UPS provides enough power during a commercial power outage to sustain analyzer system operations for the lesser of instrument shutdown cycle or 30 minutes. All contractors shall include with their quote the specific type of UPS (make, model) required for their equipment.

3.2. The contractor must provide Safety Data Sheets (SDSs) and instructions for use (IFUs) for all required supply items that are utilized on the system at no cost to the government prior to installation.

3.3. To obtain acceptable performance on the analyzer, all studies must be presented to the laboratory director or designee for acceptance and approval prior to the contractor representative's departure.

3.4. Installation support personnel shall complete daily clean-up and a final (upon installation completion) clean-up of the work area, to include any need for cosmetic repairs on walls, floorings, ceiling, etc.

3.5. The contractor shall provide a dedicated representative to perform/oversee system installation, set up, and method verification studies. The contractor shall provide all reagent/materials needed to perform 2.4., and 3.5.1. through 3.5.4.

3.5.1. Setting up Quality Control (QC) files and entering QC limits.

3.5.2. Setting up user defined patient parameters and alerts.

3.5.3. Performing correlation studies with current method.

3.5.4. Linearity verification utilizing commercial linearity material to validate all measured parameters. If commercial linearity material is not available for any parameter to validate linear range, appropriate patient samples may be used.

4. CONTRACTOR PERSONNEL

4.1. Point of Contact: The contractor shall provide dedicated point(s) of contact who shall be responsible for the performance of service and maintenance. The point of contact shall have full authority to act for the contractor on all matters relating to the execution of this contract. The contractor shall designate this individual in writing to the contracting officer representative (COR) upon contract award. The POC shall be available via telephone Monday-Friday, 7:30 AM-4:30 PM, excluding Federal Holidays.

4.2. Employee Training: The contractor shall provide on-site instrument operations training at time of equipment installation. Contractor shall provide advanced operator training on- or off-site for one government employee during the base year, and for one government employee at each option year thereafter. If off-site, this shall include transportation, food and lodging expenses. The contractor shall grant laboratory and biomedical equipment technician (BMET) staff access to available virtual training modules applicable to the analyzer system.

4.3. Physical Security: The BMET or Medical Laboratory will provide a representative to sign the contractor's representative in at applicable security check points when performing service at the McConnell AFB Clinic. Representative(s) must possess a valid driver's license and comply with installation access provisions while performing services at the McConnell AFB Clinic. The contractor shall be responsible for safeguarding all government property and shall check out with a government representative upon completion of work.

5. ADDITIONAL REQUIREMENTS

5.1. Reagents and consumables. The Contractor shall furnish all items needed to perform this contract according to all of its terms. The contractor shall provide all supplies necessary to perform correlation, precision, linearity and other studies related to installation and performance of 10,500 reportable patient Complete Blood Counts (CBCs) per year.

5.2. Special Working Conditions: All equipment, parts, materials, and services supplied by the contractor shall conform to the applicable safety standards as indicated in the current code of Federal Regulations, Occupational Safety and Health Administration (OSHA) Standards.

6. GENERAL INFORMATION

6.1. Hours of Operation: The contractor shall perform preventive maintenance services and software upgrades required under this contract between normal business hours, 0730 to 1630, Central time, Monday through Friday excluding federal holidays.

6.2. Holidays: The contractor shall not be required to perform on-site services, repairs, and/or software updates during the following federal holidays: New Year's Day, Martin Luther King's Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving Day and Christmas Day.