CSS Coagulation - Attachment 1 SOW Amendment 0007.docx

STATEMENT OF WORK

Cost-Per-Reportable Result (CPRR) Reagents and Consumables for Laboratory Coagulation Analyzers

1. Requirement.

1.1. The requirement is for a CPRR contract for Coagulation analyzers to support the following military treatment facilities (MTFs) and their workloads as indicated:

1. Naval Hospital Bremerton

2. Naval Hospital Camp Pendleton

3. 673rd Medical Group, JBER

4. 56th Medical Group, Luke AFB

5. Madigan Army Medical Center, Joint Base Lewis-McChord

6. Naval Medical Center San Diego – Core Lab

7. 99th Medical Group, Mike O'Callaghan Military Medical Center, Nellis AFB

8. 60th Medical Group, David Grant Medical Center, Travis AFB

9. Tripler Army Medical Center, Fort Shafter

10. Robert E. Bush Naval Hospital Twentynine Palms

11. Weed Army Community Hospital, Fort Irwin

12. The Government reserves the right to add additional MTFs to this Statement of Work as requirements evolve, via a mutually agreed-upon modification.

1.2. The Contractor will be required to submit monthly reports for invoicing purposes showing actual test quantities performed by each site.

2. Essential Characteristics.

The analyzers will be utilized for performing coagulation testing. The CPRR price shall include:

· One (1) base year and four (4) option years.

· All reagents, standards, quality controls, 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 reportable result. This per reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control (QC), calibration and correlation study testing that is prescribed by the Clinical Laboratory Standards Institute (CLSI);

· All necessary maintenance to keep the equipment in good operating condition. This element includes both preventive maintenance and repairs;

· Training for Government personnel to include user-level training of core staff (up to 10 users on day and evening time frame), super-user level advanced training sessions (2 upon installation and 1 per instrument installed, per contract option year thereafter). Travel and lodging will be at the

· expense of the Contractor for super-user training conducted at Contractor training location;

· Delivery, installation and removal of laboratory analyzers; and

· Peripheral equipment such as printers, Uninterrupted Power Supply (UPS) units (minimum of 1-hour capability), and all parts required to operate in accordance with proposed capabilities.

NOTE: The Government will only pay for the actual test received. Invoiced quantities shall not exceed the annual quantities listed within the SOW, of the contract. The vendor will not be reimbursed for quantities that exceed the annual estimated volume.

2.1. General Technical Requirements.

2.1.1. All equipment shall be new and not recertified nor refurbished.

2.1.2. All equipment and reagent kits shall be Food and Drug Administration (FDA) approved for use in clinical testing of human samples. All analyzers shall be capable of performing tests without requiring third-party reagents.

2.1.3. All equipment shall be capable to interface to the current electronic health record (EHR) bidirectionally (uploading order information from EHR and downloading result information to EHR).

2.1.4. The Contractor shall provide all necessary hardware and software to interface the Analyzer System with the existing military Laboratory Information Management System (LIMS) through the laboratory’s Military Healthcare System (MHS) Genesis Coding and Compliance Editor (CCE) module. The Contractor shall provide to the Government or its designated representative the operational and technical support to interface the system with the existing military lab testing LIMS until validation is complete. Completion and validation of the interface shall occur no later than 30 days after installation. This support shall be provided for the duration of the contract. The analyzer system/LIMS interface shall be capable of interfacing with the LIMS in compliance with Specifications for Transferring Information Between Clinical Instrument and Computer Systems, Approved Standard – Second Edition. Provision and support for the interface shall be included in the price of the contract.

2.1.5. The proposed solution shall be capable of automatically recovering from a downed interface without requiring manual intervention. Loss of the interface with the EHR shall not impede the system from continuing to perform laboratory testing and inputting manually entered orders to enable continued operations when connectivity with the EHR is unavailable.

2.1.6. Base equipment offered shall fully support the scope of operations and volume requirements. One analyzer or multiple analyzers may be required to meet the productivity requirements. In those instances where multiple analyzers are required, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. All proposed analyzers shall be of the same volume and speed rating.

2.1.7. All proposed multi-analyzer solutions will use the same reagents, calibrators, and controls, all provided under the CPRR unless otherwise agreed upon by the Contracting Officer and contractor. Analytic performance achieved during implementation and monitored under the Lab Accreditation Program shall remain acceptable for the duration of the contract. In the event that performance is not deemed acceptable by the Government, the Contractor shall investigate and take corrective action, up to and including replacement of the equipment at no additional cost to the Government.

2.1.8. Potential growth in volume for a specific site or restructuring of the DHA lab network may lead to a future surge in throughput requirement. Contractor shall provide analyzer(s)/reagents sufficient to enable a surge of up to 50% in volume under the scope of this contract award.

2.1.9. Reported test volumes are to be reviewed annually. If the aggregate volume across all MTFs and the contract overall decreases by 15% or more, the Contractor may request an equitable adjustment to account for the change in scope. Likewise, if the aggregate volume increases by 15% or more, the Government reserves the right to negotiate a price revision, such as tiered pricing, a volume-based discount, or credit, reflecting the increased volume.

2.1.10. The Contractor shall provide an analyzer grade water system (if required by any analyzer/system proposed); it shall be maintained by the Contractor for the life of the contract (service, tank/filter replacements, etc.).

2.1.11. The Contractor shall provide a UPS for instruments that are vulnerable to power fluctuations. The UPS will be serviced and maintained (i.e., battery replacement, unit replacement if nonrepairable etc.) by the Contractor.

2.1.12. The Contractor shall ensure exposure to bio-hazardous and chemical material is minimal with plumbed elimination of waste, primary tube sampling, and minimal handling of open container between modules (transport of tube shall be automated).

2.1.13. The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations (CFR) Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following at time of delivery:

· Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

· Waste ignitability (Reference 40CFR261.21)

· Waste corrosiveness (Reference 40CFR261.22)

· Waste reactivity (Reference 40CFR261.23)

· Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31)

· Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference

40CFR261.33)

2.1.14. The Contractor shall provide a written guide describing the proper disposal and care of all reagents, consumables, and equipment.

2.1.15. The Contractor shall also provide their own reports of effluent studies associated with their instrument.

2.1.16. The Contractor shall provide onboard environmental sensors to mitigate fire and electrical hazards.

2.1.17. There shall be access to the analyzer for the technical operator to perform maintenance.

2.1.18. As part of the ongoing process-improvement initiatives at DHA laboratories, access to all processing data from lab analyzers is essential. Therefore, it is required that all data captured and stored by the analyzer’s software be open to external analysis and available for full downloads in an Open Database Connectivity (ODBC)-compliant, unencrypted format. Backup of all databases used for system operations is to be fully accessible for review of data content and extraction.

2.1.19. Required data accessibility includes: each and every processing time stamp captured by the analyzer, reagent inventories, and classifications, patient information, audit and record edits, all personnel scans and information captured on staff involved during processing of the sample, and any other information captured by the system during the processing of the sample.

2.1.20. Moreover, it is expected that all data captured and used by the analyzer during its function at DHA labs belongs to the laboratory and shall be fully accessible by the laboratory for downloads, backups, or extracts. In addition, a full data dictionary of the tables, fields, formats, and definitions for all the databases accessed or used by the analyzer for operation of the system shall be provided. This requirement does not exclude the need for reporting described in this document but is an additional requirement so that ad hoc reporting, analysis, and system simulation can be performed by the MTF or delegated party.

2.1.21. The system shall provide a robust reporting capability and the ability to import/export delimited files at a minimum. The extraction of data shall be supported both in a data at rest modality as well as other means. Reports shall include at a minimum throughput, transaction times, user metrics for utilization and activity in the system and reagent utilization.

2.1.22. The Contractor is required to provide a continuously stocked inventory of all consumable supplies required to properly perform tests on the equipment such that equipment operations are not interrupted. Unexpected changes in methodology/technology shall be at the expense of the Contractor.

2.1.23. In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of an order from the Contracting Officer for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site, in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional emergency supplies are determined by the Contracting Officer to be required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2.1.24. The Contractor shall provide a means of tracking reagent usage and reagent level detection via a metering capability or an alternative method, for informational use only, on the CPRR. These reports shall be provided to the Government.

2.1.25. Equipment’s "Procedure Manual" or an online procedure manual in the instrument software shall be provided. The procedure manual shall be formatted in accordance with current approved CLSI guidelines.

2.1.26. Contractor shall provide Coagulation analyzers as required and meeting the testing requirements of site-specific attachment for each MTF. The automated analyzers will allow for random access, and continuous testing while loading. The analyzers shall also provide flagging capability for subsequent testing.

2.1.27. The following shall be provided for coagulation analyzers:

· Preference will be for bench top (vs. floor model instrument); Unless a floor model is dictated by large workload volume or connection to an automation line;

· Preference will be Automatic dilutions for clot based testing (at least PT/APTT);

· On-board storage of reagents;

· Preference will be for Shelf-life management of reagents (tracking on-board shelf-life) (reagents good for at least one week on-board for PT/APTT/Fibrinogen/D-dimer);

· QC (once performed) good for at least 8 hours for PT/APTT/Fibrinogen/D-dimer;

· Preference will be Cap piercing;

· Waste is self-contained for benchtop models (no drains);

· QC lockout (will not run patients if QC out or expired); and

· Reagent sequester (change lot numbers no more than once per year).

2.2. Installation and Transition.

2.2.1. Contractor shall also provide all necessary set up, installation and maintainability of Contractor-owned equipment to ensure seamless transition for daily operation.

2.2.2. The Contractor is responsible for all assembly and installation. If the Analyzer Contractor uses an Installation Subcontractor, the Analyzer Contractor shall still be responsible for providing technical support during installation. Costs for this support are to be inclusive of the CPRR prices proposed.

2.2.3. The Contractor shall be responsible for obtaining all permits, approvals, paying all fees, and complying with all applicable Governmental statutes, codes, and regulations, except as otherwise specified by the Government.

2.2.4. Installation/Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor at the Contractor’s expense as a Site Preparation Report if specified in the site specific contract instructions. When the below constraints are encountered, the Contractor shall visit the applicable site to satisfy the site specifications including but not limited to as applicable:

· Space availability;

· Power availability;

· Availability of waste drainage systems;

· Increase heat load affecting air conditioning; or Specialized ventilation if required; and

· Supply line water/ plumbing.

2.2.5. The Contractor shall supply the Government with the names of all personnel to be admitted to the job site. Contractor’s personnel shall follow MTF security procedures.

2.2.6. Contractor shall confine operations and those of any subcontractors to the project area of the site. The Contractor shall limit the use of the premises for work and for storage, to allow for work by other Contractors and construction personnel on the project. Contractor shall coordinate the use of the premises with the Government. All employees of the Contractor and subcontractors shall be restricted to the project area. Employees shall not enter the building except as required to complete the work covered by this project.

2.2.7. The Contractor shall at all times enforce strict discipline and good order among Contractor employees and shall monitor performance expectations for assigned tasks and take corrective action if Contractor commitments are not met.

2.2.8. The Contractor may be required to cordon off the work area via visible barriers or some other means of containment.

2.2.9. Delivery, storage and laydown of materials shall be coordinated with the Materiel Management Department Head, or designee, at the respective MTF. Contractor or subcontractor shall have secured base or post access for install, training, and implementation team members. Additionally, Contractor shall secure lodging and other logistical support required by team members at no additional expense to the Government. The MTF Laboratory, Facilities, and Biomedical Engineer departments’ support staff will ensure lab access, light, good working space, and a sponsor for the duration of the visit. Days and hours of access may have to work around peak lab operating hours.

2.2.10. The Contractor shall secure, at Contractor’s expense, required credentialing or clearance process for representatives to access Bases, or other entity’s requirements in order to render all services and deliverables of the contract.

2.2.11. The Contractor shall be responsible for overall cleanliness of the work area during installation and shall make daily cleanup of the area, removing the collected materials to the designated area identified by the laboratory staff. Combustible materials shall not be allowed to accumulate and shall be removed from the installation site daily. All working areas shall be incorporate the removal of dust and debris (broom-cleaning or equivalent). If the Contractor fails to clean up at the completion of the workday, the Government may do so and the cost thereof shall be charged to the Contractor.

2.2.12. The Contractor shall store material, equipment, and tools only at locations designated by the Government and shall not obstruct any roads, aisles, doors, or passageways. The Government assumes no responsibility for losses due to theft of Contractor’s stored materials.

2.2.13. The Contractor shall be responsible for the daily cleanup of the work area.

2.2.14. The Contractor shall perform, to the satisfaction of the Government, the MTF Laboratory Director and Contracting Officer’s Representative (COR), validation studies per CLIA / National Committee for Clinical Laboratory Standards (NCCLS) including quality management guidelines for essential laboratory operations, method correlation, linearity verification, precision, carry-over, normal reference range validation, and blood collection tube validation for troubleshooting purposes.

2.2.15. Included with the analyzer acquisition is comprehensive training for Laboratory personnel.

2.2.16. Diagnostics Systems Specialist shall be available on site to facilitate the analyzer implementation.

2.2.17. Technical Specialist (TS) shall be available on site to conduct user-level training. These personnel shall assist with the initial instrument qualification testing using onboard analyzer and MTF identified patient samples for parallel testing. All validation and method verification testing shall be completed in accordance with manufacturer specifications and the DoDM 6440.02. TS shall provide the MTF CLSI formatted standard operating procedures (SOPs). These shall be provided digitally or electronically for MTF customization.

2.2.18. The Contractor may propose new technology anytime during the contract, provided the existing global cost per reportable price and DHA ATO status remains unchanged.

2.2.19. The MTF may decide to upgrade their current equipment, i.e. replace existing equipment with newer models to enhance operational capability. The Contracting Officer and Contractor may do so under a signed supplemental agreement provided that the upgrade does not increase the global CPRR price or negate any other contractual terms.

2.3. Replacement Parts/Upgrades.

· The Contractor and its representatives shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. If replacement parts require shipment, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

· The Contractor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the original equipment manufacturer (OEM).

· Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the Contractor.

· All replacement parts shall be new and certified as OEM replacement parts.

· The Contractor shall provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than during the first scheduled PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the Contractor shall provide installation within 30 days of release regardless of PM schedules.

· With approval from the Government, the Contractor may perform hardware/software upgrades as they become available and perform onsite follow-up quality testing to ensure updates do not compromise system functionality.

2.4. Reagents Supply and Delivery.

· All supplied items and reagents shall be certified for use with the Contractor equipment provided.

· The reagents delivered shall have expiration dates no less than 6 months (preferably 12 months) from the delivery date, with the exception of “fragile” analytes for which maximum available dating will be provided. The reagents shall function properly, passing all lot-to-lot tests. Calibrators and controls shall function properly and test within the ranges set by the manufacturer. The calibration will remain stable for the duration stated by the manufacturer.

· All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) will be marked in a clear manner with a label. The label will be placed in three (3) or more locations on the container (top & two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

· Analyzer equipment-related services are to be performed -at addresses incorporated on the site-specific attachment for each MTFs (see Coagulation SOW - Attach #1 Site Specific Information).

· Deliveries of analyzer equipment and supplies are anticipated to be begin and end off the current existing contract for each MTF. All analyzers regardless of the location shall be functioning to provide testing and Live on all locations by 10/01/2027. Including those MTFs that will transition to a new vendor if the awardee is not the current incumbent.

2.5. Service/Maintenance.

· Normal Business Hour Maintenance Coverage will be in accordance with the lab hours for each MTF as incorporated on the site-specific attachment for each MTFs (see Coagulation SOW - Attach #1 Site Specific Information). Contractor shall provide full-service PM when necessary.

2.5.1. The Contractor shall provide OEM-trained, experienced, English-speaking personnel. The Contractor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

2.5.2. The Contractor shall provide emergency equipment repair and preventative maintenance on all analyzers and any incremental support equipment (printers, water system, UPS, etc.) offered according to the following terms for the duration of the contract:

· A technical assistance center shall be available by telephone 24 hours per day with a maximum call back response time of 2 hours.

· Routine equipment repair service shall be provided during all laboratory operational hours as specified in the “Lab Hours” table above. Maximum response time shall be 24 hours. Any Status of Force Agreement (SOFA) at an OCONUS location is not applicable to Contractor representatives.

· A Contractor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (24) hours after receipt of trouble call. Equipment shall be repaired and deemed operational within 48 hours. If equipment issues cannot be completely resolved within 48 hours, the Contractor shall provide a detailed plan for restoration of services and scheduled corrective action/maintenance to each MTF within 48 hours of initial on-site service.

· The Government’s request for corrective maintenance will be placed by Biomedical Engineering Division (BIOMED) personnel, directly to the Contractor or its representatives. Corrective maintenance shall be completed during the normal work hours for each MTF as specified in the “Lab Hours” table above.

· Certain circumstances may dictate the need for repair service to be conducted outside of routine business hours. All such arrangements shall be coordinated between the Contractor and MTF laboratory personnel as part of separate maintenance contracts between individual MTFs and the Contractor.

· The Contractor’s response to requests for service may include telephone consultation with the equipment user/operator and a Contractor field service engineer (FSE). Telephone consultation shall:

· provide instruction in determining operator error

· determine the most likely cause of the problem

· determine if resolution of the problem requires the dispatch of an FSE; and

· identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM

2.5.3. Preventive maintenance calls shall be aligned with manufacturer’s specifications.

2.5.4. All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), FDA, and National Institute of Standards and Technology (NIST) standards.

2.5.5. The Contractor shall have and provide to its representatives its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract.

2.6. Performance Requirement Summary and Acceptance Testing.

· Implementation/transition timeframe – The delivery of the requirements described in this SOW shall be specified in the “Delivery Information” section of each contract line item number (CLIN) for each MTF.

· Within one month from the date of award of the contract, the Contractor shall develop a preliminary implementation schedule for the program.

· Implementation/transition timeframe. Contractor’s submitted implementation plan shall not exceed 60 days for the transition of all equipment related services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations. Contractor shall not be penalized for implementation timelines that extend beyond the 60-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate the contract for cause under the Termination for Cause clause of the contract. At the end of 60 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

2.7. Standard and Quality of Performance.

· This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any contract at an effectiveness level of 95% or more. If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for patient results reported during the 90-day acceptance period.)

· Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than the minimum of 100 hours.

· The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the Government technical representative or customer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 95% in each month of the term of the agreement for equipment.

2.8. Equipment Uptime Rate and Calculation.

· The Contractor shall maintain an overall uptime rate of 95% or better for all analyzers at each MTF. Uptime is equal to equipment availability minus down time. Uptime and downtime are values used to calculate the mean time between failures (MTBF).

· Uptime is calculated on a rolling 6-month basis. Until the Contractor has at least 6 months of performance experience at the MTF, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

· Variables Definitions:

· U= Possible Equipment Uptime (100%)

· H= Hours of Coverage per day

· H1= Begin Coverage Time during each day

· H2= End Coverage Time during each day

· A= # of covered days of the week

· W = Weeks of Coverage in a Year (52)

· C= Uptime Commitment (95%)

· Variables Values: See Coagulation SOW - Attach #1 Site Specific Information.

· Calculations:

· H = (H2 – H1) / 100

· U = H x A x W

D= Hours of Calculated Downtime (Unknown) T= Total Actual Uptime Percentage (Unknown) Δ= % difference from Uptime Commitment (Unknown) T= (U – D) / U Δ= (C – T) x 100

NOTE: Downtime ends once the system is available for full clinical use.

2.9. Government Responsibility.

· The Government shall perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The Government shall maintain appropriate records to satisfy the requirements of this paragraph.

· The Government will operate the system in accordance with the instruction manual provided by the OEM.

· The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by Contractor personnel.

2.10. Contractor Responsibility.

· The Contractor shall provide upgrades to both the equipment hardware and software to maintain the integrity of the system and the state-of-the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers.

· Ancillary support equipment. The Contractor shall provide, install, and maintain through the life of the contract, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

· The Contractor shall be responsible for the repair and/or replacement of damaged Government-owned equipment and property, resulting from the negligence of the Contractor or its representatives. All such replacement or repair shall be completed at the Contractor’s expense and shall be inspected to the satisfaction of the Contracting Officer or his/her appointed representative.

2.11. Contractor Report Requirements.

· During normal duty hours, Contractor FSE personnel shall check-in with the Biomedical Engineering Division (BIOMED) upon arrival at the Government site and again prior to departure. The Contractor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, Contractor FSEs shall notify the Officer of the Day Desk and the systems’ operator designated by BIOMED personnel through the on-site laboratory staff both verbally and in writing.

· A service or malfunction incident report shall be furnished to the COR, Laboratory and BIOMED within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

· Name of Contractor

· Contract Number/Contract Number

· Name of Field Service Technician performing service

· Contractor log/control number

· Date and time notified

· Date and time of arrival

· Description of problem reported by user

· Equipment identification factors to include manufacturer, make, model, serial number, and facility equipment control number (ECN)

· Itemized description of service performed to include labor and travel costs, parts used, parts cost, part number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action take or recommended

· Time spent for repair; and

· Proof of repair that includes documentation of a sample run of calibration verification or QC verifying acceptable performance as may be applicable; or, if problem was not resolved, pending action

· Total billing cost

· Signatures

· Field Service Technician performing services

· BIOMED representative verifying service rendered

· If agents/subcontractors are used in the performance of repairs, said agents/subcontractors shall be identified on the service report by company name, point of contact, and contact information (i.e. telephone number and email).

2.12. Ownership of Equipment.

· Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of contract(s), at termination and/or replacement of equipment, shall remove the equipment at the expense of the Contractor. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for decontaminating, packing, and shipping required for transport of the analyzer.

2.13. Removal of Government Property.

· No equipment shall be removed without the approval of the Government technical representative and Materials Management Department (MMD) of the MTF. Property passes for equipment removal shall be obtained by the Contractor via the MMD of the MTF. Any failure to obtain such passes, which results in detainment or prosecution of service Contract personnel, is the sole responsibility of the service Contractor and their personnel.

· The Contractor shall provide a detailed description of removed items on the Contractor’s company letterhead. For associated items/accessories, the Contractor shall provide a detailed written description and quantities of items to be removed. Descriptions shall include, at a minimum, the manufacturer’s serial numbers and facility ECNs of all equipment/items removed. If items/sub-assemblies/accessories are “repaired by replacement,” a detailed description of replaced items is to be included upon return of repaired components.

· No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a Contractor determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the Contractor. The Contractor shall provide insurance coverage for damage to or loss of equipment while in Contractor or service Contractor’s custody.

· Regarding patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing personally identifiable information or patient health information from the Government site. Equipment hard drives and Solid State Drives (HDD & SSD) shall be removed by MTF personnel prior to equipment removal from the site. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If HDD / SDD are to be replaced, the HDD / SSD in disrepair shall be left at the MTF for disposal.

· Hard Disk and Solid State Drives (HDD & SSD): In regards to patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the MTF. HDD nor SSD shall ever be removed from the MTF, by the Contractor under this maintenance agreement. Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the Command Equipment Manager.

2.14. Service Beyond the Scope of the Contract.

· The Contractor shall immediately, but not later than twenty-four (24) consecutive hours after discovery, notify BIOMED, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment which the Contractor considers they are not responsible for repairing under the terms of this contract.

· At the same time of the notification, the Contractor shall furnish BIOMED with written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

2.15. Information Assurance.

· The Contractor shall comply with all applicable DoD Cybersecurity/Risk Management Framework (RMF) requirements identified in the attached DHA Contracting Requirements for Medical Device and Equipment (MDE) Cybersecurity/RMF dated January 17, 2024.