PWS.pdf

Classified as Internal

Department of Defense Defense Health Agency

Performance Work Statement

Hematology Analyzer

Directorate of Clinical Support Services

Laboratory

Solicitation Number:

Version: 1.0

Date: 7 December 2023

Classified as Internal Classified as Internal

PART 1

1.0 GENERAL INFORMATION

1.1. This is a services contract to provide one (1) Hematology Analyzer, capable of performing the Complete Blood Count (CBC) with six-part WBC Differential. The CBC is a test panel that is requested by a credentialed provider which provides information about the cells in a patient’s blood. A clinical laboratory scientist performs the requested testing and provides the requesting provider with results of the patient’s CBC. The CBC includes a white blood cell count, red blood cell count, hemoglobin, hematocrit, red blood cell indices (information on red blood cell size and hemoglobin content), a platelet count as well as a white blood cell differential (neutrophils, lymphocytes, monocytes, basophils, immature granulocytes, and eosinophils are enumerated).

1.2. Description of services/introduction. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials (including all reagents, calibrators, consumable parts, software upgrades and accessories), supervision, training, travel, labor and other items and non-personal services necessary to deliver, install, and maintain the hematology analyzer as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3. Background. The contractor shall provide all services, materials and equipment per the cost per test agreement in regard to SIN 66 category 615 19 “Blood cell analyzers for clinical hematology and related chemistries, supplies and consumables” for one (1) low to mid-volume hematology analyzer, located in building 559, 15th Medical Group (MDG), Clinical Laboratory, Joint Base Pearl Harbor-Hickam, Hawaii ensuring dependable and reliable operation of the equipment. The scope of work performed under these specifications includes the furnishing of all labor, equipment, materials, and parts to perform all repairs on equipment listed, to ensure continued operation at their designed efficiency and capacity. The cost-per-test price shall include costs covering the analyzer, including peripherals, all reagents, standards, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the contractor's equipment and necessary for the generation of a test reportable result. This cost per test result will also encompass all costs associated with dilution, repeat and confirmatory testing required, producing a single test reportable, and include the materials and all other costs associated with quality control, calibration, and correlation study testing that is prescribed by the Clinical Laboratory Standards Institute (CLSI).

1.4. Objectives. The hematology analyzer should be capable of running a six part differential (percent and absolute values needed). The analyzer should be capable of auto loading, auto re-run, and auto-dilution.

The analyzer (to include all instrumentation, computer workstation, printer, power supplies, required clearance, etc.) should fit within a six feet workspace each not exceeding the height, width, and depth of 20in x 20in x 30in and a maximum weight of 150 lbs. The electrical requirements must meet 100-120V. Operating temperature must be within 15⁰C-30⁰C. Operating humidity must be within 30%-85%, ambient relative.

1.5. Scope. Analyzer 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 analyzer shall have the method performance specifications (including accuracy, precision, linearity, correlation, and normal reference study) performed onsite and training completed by the contractor upon installation of the analyzers. The contractor is responsible for the removal of the clinical Hematology analyzer at the end of the contract period or at the government’s discretion.

*The contractor shall provide all validation reagents, calibrators, quality control (QC), and consumables required to perform installation and initial validation.

*The contractor shall provide any special items required during initial validation to include but not limited to linearity materials (i.e. Maine standards or other commercially available standards).

*Key operator (super user) training provided for two staff member per analyzer for base year and one staff member per year thereafter (each option year). All travel expenses including lodging, airfare/travel, and meals should be provided by the contractor.

*24/7 customer service hotline for over the phone trouble shooting.

*No later than 24 to 48 hours after telephone notification, to a monitored contractor emergency telephone number to be provided by the contractor to clinical laboratory. Perform service maintenance to industry standards.

*Ensure that only FULLY QUALIFIED FIELD ENGINEERS & TECHNICIANS who have gone through original equipment manufacturer (OEM) or comparable third-party service schools for the above-mentioned equipment shall be employed in the performance of any and all work performed under this contract. The highest standard of professional capability and electrical/mechanical workmanship is to be maintained throughout the life of this contract.

*Perform required preventive maintenance (PM) as defined by the manufacturer and /or College of American Pathologists (CAP) standards. The contractor will provide in writing the schedule for routine PM and service on all covered equipment. Scheduled PM(s) will be coordinated with the clinical laboratory and shall be documented, with a copy of that documentation being provided.

*Make repairs to the extent necessary (as determined by inspection tests or disassembly) to ensure a functional system that will efficiently serve its intended purpose. The contractor is responsible for all costs to include parts, shipment, and labor for the analyzer listed in the PWS.

*Correct inoperable conditions in a timely manner with a response, in person, time of no greater than next day for analyzer inoperability. Service hours for the 15th MDG Clinical Laboratory are Monday-Friday 0700-1630, Hawaii Standard Time.

*Provide the work necessary to restore the equipment to a serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts replacements are not necessary.

*Equipment improvements/modifications shall be made only on written approval.

*Notify the clinical laboratory immediately upon receipt of OEM or replacement parts/equipment safety recall notices.

*Ensure that original design and functional capabilities will not be changed, modified, or altered unless the clinical laboratory authorizes such changes.

*Provide suitable modern recommended repair equipment/tools required for the satisfactory execution of all repairs made.

*Furnish manufacturer OEM approved lubricants and lubricate wear points within the equipment.

*Extend to the government all commercial warranties or replacement parts, consistent with standard industry practices.

*Maintain an adequate spare parts inventory on parts with a history of high failure/replacement rates on-site for the customer’s use.

* If extensive reagent/calibrator, quality control material is exhausted during troubleshooting, it is the contractor’s responsibility to replenish that supply to the government.

*If reagent requirements change during the period of performance, it is the vendors responsibility to provide the reagents necessary to perform all testing covered by the original contract documentation.

*Must be capable of interfacing to the government laboratory information system, Military Health System (MHS) Genesis.

TITLE TO EQUIPMENT: The government shall not assume possession of any part of the equipment. The contractor retains ownership to title thereof.

LIABILITY: The contractor shall not be liable for any loss, damage, or delay due to any cause beyond his reasonable control including but not limited to, acts of government, strikes, lockouts, fire, explosion, theft, floods, riot, civil commotion, war, malicious mischief of acts of God.

UTILITIES: The contractor may use government utilities, (electrical power, compressed air, and water) that is available and required for any service performed under this contract. The building engineer, to ensure compatibility with the Hickam Clinic’s electrical wiring and equipment, must approve contractor electrical equipment.

ACCESS TO EQUIPMENT: The contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on duty personnel responsible for such equipment.

CONTRACTOR CHECK-IN/CHECK-OUT: The contractor or his representative is required to report to the clinical laboratory for Visitor Badges during the hours of 0730-1600 hours, Monday through Friday, prior to and upon completion of any service/repair performed.

GOVERNMENT PERSONNEL: 15 MDG Clinical Laboratory employees will not perform maintenance or attempt repairs to equipment, outside what is expected by the end user as required, while such equipment is under the purview of this contract unless agreed to in writing by the contractor.

PARTS AVAILABILITY: To ensure minimal downtime to equipment, the contractor shall maintain replacement repair parts and materials necessary to perform each repair or supply said parts and materials within (1) one day.

COMPENSATION: Labor: All compensation for labor is included in the contract price. Parts and Materials: All compensation for parts and materials is included in the contract pricing.

Parts/Supplies Quality: Parts and Supplies provided under this contract shall be guaranteed to be equal in all respects, including performance, interchangeability, durability and quality to the OEM parts when new or as presently recommended by the manufacturer.

Services include preventative maintenance, software upgrades, firmware upgrades, operational checks, and adjustments to on-site equipment in order to ensure the equipment is fully operational and within OEM specifications. The contractor shall accomplish fully operable hematology analyzer up on completion of any service, parts replacement, hardware upgrade, software upgrade, etc. prior to end of service.

1.6. Period of Performance (PoP).

Base - From: 01 October 2024 to 30 September 2025 Option 1 - From: 01 October 2025 to 30 September 2026 Option 2 - From: 01 October 2026 to 30 September 2027 Option 3 - From: 01 October 2027 to 30 September 2028 Option 4 - From: 01 October 2028 to 30 September 2029

1.6.1. Transition: Transition-in/transition-out period, not required if incumbent vendor.

Otherwise, ninety (90) days if not incumbent vendor.

1.7. Administrative specifications.

1.7.1. Place of performance: The work shall be performed at:

15th Medical Group - Clinical Laboratory Department 755 Scott Circle

JBPHH, HI 96853

1.7.2. Recognized Federal holidays:

New Year’s Day Labor Day

Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.7.3. Hours of operation: The contractor is responsible for conducting business Monday thru Friday except Federal holidays or when the government facility is closed due to local or national emergencies, administrative closings, or similar government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the government facility is not closed for the above reasons.

1.7.4. Emergency Services: on occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.8. Contractor travel. Contractor shall not be authorized travel expenses.

1.9. Other Direct Costs (ODC). N/A.

1.10. Quality. Quality Control (QC): FIELD SERVICE REPORTS: The contractor or his representative shall furnish to:

The day of a legible copy of the Field Service Report detailing work performed is to be submitted. The contractor or his representative shall complete the government copy of this Field Service Report by including the following:

*Date & Time notified *Date & Time Arrival *BCN (Bar Code Number) Type, serial # and model # of equipment *Time spent repairing/servicing *Description of malfunction *General description of replaced parts and service performed *Comments as to cause of malfunction *Recommendations to prevent future occurrences

FIELD SERVICE REPORTS ARE REQUIRED PRIOR TO APPROVAL OF ALL INVOICES

The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system.

1.10.1. Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

PART 5

2.0 SPECIFIC TASKS

2.1. Deliverables. All analyzer and accessories technology, testing methodologies, quality control, consumables, spare parts used in routine user maintenance, and reagents used onboard the analyzers will be approved by and compliant with the U.S. Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The analyzer performance characteristics must meet requirements for accuracy and precision as defined in the 1988 Clinical Laborato1y Improvement Act (CLIA'88) and the CLSI. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment and reagents shall be in compliance with OSHA requirements.

All equipment and accessories shall be new from the manufacturer. Used or refurbished equipment, or equipment obtained from a third party shall not be accepted.

2.2. Analyzer Technical Features.

*Be compatible with and maintain bi-directional interface with HL7, the DOD Laboratory Information System, MHS Genesis.

*Be capable of reading specimen Code 39 barcode labels.

*Provide a full CBC test panel using an FDA-approved methodology, e.g. fluorescent flow cytometry technology. This CBC panel will include: White Blood Cell (WBC) count, Red Blood Cell (RBC) count, RBC indices (measured or calculated), platelet count, and six-part WBC differential.

*Possess onboard approved FDA methodology, e.g. fluorescent technology, for the measurement of platelets to confirm the accuracy of low platelet counts and to provide an accurate platelet count in the presence of interferences (such as RBC fragments).

*Have a generous WBC and platelet linearity range to facilitate accuracy of testing on patients with very high WBC counts or platelet counts as seen in various disease states.

*Have a closed, open and capillary specimen sampling/testing mode. A small specimen volume requirement is desired due to the large population of neonatal, pediatric and geriatric patients referred to and treated by the client; desirable specimen aspiration size: No more than 100µL for the open and closed sampling modes.

*Sample loading capacity minimum of 10 samples per rack.

*Provide an FDA-cleared red cell distribution width SD and CV.

*Analyzer must possess specimen clot detection capabilities.

*Analyzer must possess a walk-away shut down and re-start capability.

*Analyzer must combine flagging information from multiple channels to optimize diagnostic information.

*Analyzer must offer customized suspect flag settings to optimize review rates.

*Analyzer unit will be supplied with an uninterruptible power supply (UPS). The UPS is a self-operated unit that provides enough power, during a commercial power outage to the analyzer, to ensure that the Hematology analyzer system remains operational. In the event of a power interruption, the UPS must be capable of sustaining power for a minimum of 10 minutes.

*Analyzer system will be supplied with a printer.

2.3. Reagents.

*Through a fixed monthly payment contract, the contractor will provide all analyzer automation, necessary reagents, quality control, spare parts for user level maintenance, and consumables in support of in-house CBC and associated testing at the 15 MDG laboratory. Additionally, services include recurring shipment of materials and reagents at no cost.

*The contractor will provide reagents with at least a six-month shelf life.

*A single quality control material must provide measurements for all parameters on the system namely CBC panel to lessen the need for and the use of multiple QC materials.

*The contractor will provide quality control materials with a shelf-life lot stability of at least 80 days which will place less of a burden on the clinical laboratory of having to constantly evaluate new quality control lots and performing correlation studies to confirm new control lot performance.

*Reagent menu requirements:

TEST NAME ANNUAL USAGE

Complete Blood Count (CBC) 4160

2.4. Calibrations.

*The contractor will perform all analyzer calibrations every six months or as recommended by manufacturer or quality control data and after major maintenance or service and provide all calibration materials at no cost to the government.

2.5. Method Performance Verification.

*The contractor will provide trained technical service representative(s) to install instrumentation and assist in performing instrument-to-instrument correlation studies and validation studies necessary to confirm acceptability for analyzer functionalities body fluid analysis. All validation data will be collected, calculated, and organized into final validation reports for the client to review and approve.

*The analyzer shall have the method performance specifications (including accuracy, precision, linearity, correlation, and normal reference study) performed onsite and training completed by the contractor upon installation of the analyzers.

*The installation and validation period shall not exceed more than 30 calendar days (from the time of installation).

2.6. Service/ Preventive Maintenance.

*A service plan must be included in the contract for the base year as well as all option years. This service plan will include at a minimum all of the following: 24 hours a day/7 days per week telephone technical support with on-site technical support dispatched as necessary, provide hardware and software upgrades when available at no additional cost, and analyzer preventative maintenance IAW OEM specifications performed by a qualified service engineer at no additional cost.

2.7. Value Added Services:

*Approved DHA Authorization to Operate (ATO).

*Capable of providing an internet-based quality control program.

*Capable of providing standardized offerings (standing orders for reagents and controls).

*Capable of providing automatic notification and documentation of required calibration verification procedures.

*Capable of offering remote support capability for analyzer troubleshooting purposes.

*Provide Professional Services to expedite project implementation timeline.

2.8. Maintain Current Hematology Capabilities. To maintain current operation capabilities and lessen the impact of having to change and update large numbers of hematology policies and procedures, it is optimal for the hematology analyzer to have the following characteristics:

*Preferred system should be able to provide a fully automated and reportable Complete Blood Count (CBC), 6-part differential.

*Preferred system should not require more than 3 control vials for daily quality control runs for complete blood count, 6-part differential.

*Preferred system should not require more than 50µl sample aspiration volume to perform Complete Blood Count (CBC), white blood count differential analysis as a way to reduce redraws and allow for maximized test utilization and efficiency.

*Preventative maintenance of system should be self-contained and automated to increase laboratory productivity.

*Preferred system should offer standardized reagents, technology, and quality control across all offered solutions.

*Preferred system should provide vendor completed calibration adjustments and verifications in accordance with accreditation requirements.

*All current menu of test parameters to be maintained and FDA approved on new hematology system.