Mirion Statement of Work 2026_revised.docx

Statement of Work

5 Pages

Statement of Work for Site Agreement for Mirion Equipment

Introduction Due to the complex nature and high levels of technology used in modern nuclear measurement applications, there is a continuing need for comprehensive services to ensure the maximum efficiency and reliability for DRS Analytical Lab Instruments. This Statement of Work describes an agreement to provide all onsite, remote and factory services in support of National Institutes of Health site relating to nuclear measurements involving Mirion covered equipment and associated applications including hardware and software support, onsite services, upgrades, training and other service activities described below. The support services in the statement of work will be delivered on site at National Institutes of Health.

Schedule A project manager who is Contracting Officer Representative certified will be assigned as primary point of contact for scheduling and approving prospective work. Following contract award, the incumbent will immediately assign a Field Support Engineer (FSE). This person will review the customer's detailed requirements as applicable, but not limited to: hardware, existing software versions, training requirements, site access requirements and site-specific customizations. Together, the assigned FSE will develop a process to ensure maximum efficient utilization of Mirion and National Institutes of Health resources. Technical issues will be reviewed by the Mirion scientific staff for resolution. The incumbent's engineers will review issues relating to the distribution of clients and servers, networking, remote access to systems, unique system interfaces, and software version compatibility.

Scope The intent of this agreement is to provide comprehensive services for equipment listed below. This list shall be reviewed at the beginning of each agreement period to ensure accuracy. Other equipment, including other manufacturer's equipment, may be added upon mutual agreement and may require additional cost.

All newly purchased Mirion equipment will automatically be covered at no charge during the product's warranty period. A grace period of coverage is provided from the end of the product's warranty period until the next renewal year. At that time of renewal, the product coverage will be charged at the applicable contract coverage price rate. Installation time and cost for new products may be performed under this support agreement using available contract time.

Site and Equipment Access In order to ensure maximum flexibility and efficiency, Mirion personnel will have complete and free access to the equipment when providing service called for in this agreement. Security escorts or clearances are the responsibility of National Institutes of Health. We reserve to have the flexibility to use contract time for any of the services mentioned below. Time is utilized for On-Site Field Support (Standard Service) functions such as Troubleshooting, Performance Verifications, Installations, Upgrades, and System set up.

Required Services System Management and Administration Support

· System monitoring and verification to protect the integrity of the Operating System environment and running processes

· Operating System optimization and tuning for maximized application performance

· Analysis and maintenance of the Operating System logging system

· Installation of operating system and application updates and service packs to ensure that all systems are operating with the most current software

· Installation of software licenses and layered products

· Routine system and data backups including data archival Routine Preventive Maintenance Support

· Inspect all equipment and systems for signs of abnormal operation

· Preemptive replacement or repair of such equipment demonstrating signs of impending failure

· Thoroughly clean electronics and systems to prevent heat buildup causing premature failures

· Verification of all electronics and system voltages ensuring they fall within appropriate tolerances

· Clean, lubricate, and adjust systems to prevent mechanical system failures Calibration Services Whole Body Counter (WBC) Calibrations:

The incumbent will provide all labor and equipment necessary for complete system calibration at the customer site. Calibration procedures will be tailored to optimize measurement accuracy for the specific system being calibrated. All calibrations must be performed by a qualified professional, using appropriate phantoms and NIST traceable standard radionuclide sources. New energy, FWHM and Efficiency calibration files are created and then validated by performing a series of replicate verification counts for each geometry. Efficiency calibration geometries include lung, total body, thyroid and GI tract. The phantoms are selected to optimize WBC system performance as specified in ANSI N13.30. After creation and verification of the new calibration files, replicate QC measurements are performed to establish baseline QC limits for evaluating long term system stability. QA/QC program recommendations and WBC measurement uncertainty limitations are discussed with National Institutes of Health personnel. All calibration measurements and results are documented in a formal report and calibration certificate. A complete calibration typically requires 12-16 hours of uninterrupted WBC system use during a two-day period onsite. All final documentation will be delivered within 14 days following calibration.

High Purity Germanium Gamma Spectroscopy System Calibrations The incumbent must provide all labor and equipment necessary for complete system calibration at the National Institutes of Health site. Calibration procedures will be tailored to optimize measurement accuracy for the specific system being calibrated. All calibrations must be performed by a qualified professional, using appropriate NIST traceable standard radionuclide sources. New plateau, discriminator settings, background and efficiency calibrations are performed and then validated by performing a series of replicate verification counts for each counting geometry. Efficiency calibration geometries are nuclide, matrix, and geometry specific. The radioactive standards are selected to optimize gamma spectroscopy system performance as specified in ANSI N42.25. After creation and verification of the new calibration, replicate QC measurements are performed to establish baseline QC limits for evaluating long term system stability. QA/QC program recommendations and gamma measurement uncertainty limitations are discussed with National Institutes of Health personnel. All calibration measurements and results are documented in a formal report and calibration certificate. A complete calibration typically requires 8-16 hours of uninterrupted gamma spectroscopy system use during a two-day period onsite. All final documentation will be delivered within 14 days following calibration.

Upgrade, Installation and Familiarization Support The incumbent must setup, configure and verify functional operation of these systems while providing system and software familiarization to the end user. This contract covers standard system setup at the National Institutes of Health site:

· Hardware Assembly

· Integration of Electronics and Peripherals

· Software Installation

· Verification of System Operation

· Operator Familiarization

· Introduction to Basic Modes of Operation

· Explanation of Hardware Configuration

· Overview of Major Features of Application Software Training Training, both initial and requalification, is key in maintaining the safety culture required for long term success. The incumbent shall provide site-specific versions of standard courses, as well as customized training services. These courses are intended to provide refresher training to experienced staff, as well as introductory training to new personnel. Courses should be flexible in terms of course content and length and can be offered in both classroom and laboratory environments to ensure adequate hands-on experience. The incumbent can also develop and deliver customized educational solutions to meet lab requirements.

Software Support Program The incumbent must provide support for all the Mirion software purchased by the National Institutes of Health to operate and fully utilize the applicable Mirion equipment. To ensure software compatibility between existing software applications on each system and future updates, it is required that all necessary software applications be licensed on the National Institutes of Health system. Prior to contract initiation, the software packages licensed on each system must be at the current revision levels supported by Mirion. If not, a one-time software and documentation update must be purchased for each system. All Software modifications conform to IEEE 730.1 guidelines, or equivalent.

Software and Documentation Updates The incumbent must provide the latest software and documentation updates released by Mirion for each system covered. This ensures that all systems supported receive identical software distributions approved by the Mirion Quality Assurance Department. Each software update includes detailed release notes describing the modifications incorporated into each software program.

Software Modifications Conform to IEEE 730.1 Guidelines, or Equivalent All Mirion software modifications must be performed in strict adherence to IEEE 730.1 Guidelines. This includes the generation and approval by Mirion of the Software Requirements Specification (SRS), Software Design Document (SDD), and the Software Verification and Validation Test Plan (SWP). When the SWP is completed by the Mirion Quality Assurance Department a Software Verification and Validation Report (SWR) is generated for approval. When the SWR is approved, the software is released by the QA Department for distribution. Complete document control is maintained at all times by the Mirion Quality Assurance Department.

Immediate Notification of Critical Software Problems The incumbent will immediately notify National Institutes of Health if a licensed software package is affected by a critical software problem. Notifications are sent to the designated system manager and include a description of the problem and programs affected. When applicable, temporary "work around" solutions are provided with each notice. These notices are generated (but not limited to) the following cases:

· Program output values appear reasonable but are incorrect.

· Internal data files are being altered or corrupted.

· Program will not execute correctly under certain conditions.

For software issues that do not constitute a critical problem, the incumbent will create a Software Performance Report (SPR). This notice conveys relevant technical information used to correct or clarify (a) misleading or incorrect documentation or (b) the operation of a particular software application.

Remote Access Support The incumbent may provide the capability for Technical Support personnel to remotely access computers to expedite the solution of problems or operational questions. Mirion access to National Institutes of Health computers is controlled by the National Institutes of Health.

Software Support for Mirion Supplied 3rd Party Software Software support can be provided for 3rd party software applications supplied by Mirion. This benefit provides phone support and all software and documentation updates released during the support period. Mirion will provide all applicable 3rd party software support telephone numbers and required access codes. Software support calls for 3rd party software will be coordinated through the Mirion Technical Support Department.