0001 SOW - Chemistry CPRR and Automation - 092826.docx

?.## STATEMENT OF WORK (SOW)

Dated: September 28, 2026

TITLE: Chemistry Cost Per Reportable Result (CPRR) Agreement with Automation System

1. Purpose

This Statement of Work (SOW) defines the scope, objectives, deliverables, responsibilities, pricing structure, and implementation requirements for the provision of Chemistry Cost Per Reportable Result (CPRR) services, including an automation system, at the Bay Pines VA Healthcare System. Under the CPRR pricing methodology, the contractor shall provide the equipment, reagents, consumables, maintenance, service, and other required support specified in this SOW at the established price per reportable result.

The purpose of this fixed price indefinite delivery indefinite quantity (IDIQ) contract is to provide comprehensive chemistry laboratory testing services through a Cost Per Reportable Result (CPRR) pricing model that includes chemistry analyzers, automation systems, reagents, consumables, maintenance, middleware, interfaces, training, and operational support. The contract is intended to improve laboratory efficiency, standardize operational costs, enhance patient safety, reduce downtime, and support timely and accurate reporting of chemistry test results within the VA electronic health record environment.

2. Background

Bay Pines VA Healthcare System requires a fully integrated chemistry laboratory solution under a Cost Per Reportable Result (CPRR) pricing model. The solution shall be capable of interfacing with existing Veterans Health Administration (VHA) systems, laboratory analyzers, and associated clinical information systems.

The Chemistry CPRR solution, including the automation system, shall support:

· Automated chemistry laboratory result processing

· Instrument connectivity and interface management

· Workflow standardization

· Quality assurance and quality control tracking

· Data integrity and audit compliance

· Reduction in manual intervention and transcription errors

· Improved turnaround time for laboratory results

· Regulatory and VA policy compliance

The system will integrate into the existing VA information technology environment while maintaining cybersecurity, privacy, and interoperability standards.

3. Scope of Work

3.1 The Contractor shall provide all labor, supervision, materials, equipment, software, transportation, installation, configuration, validation, maintenance, and support required to provide a fully operational integrated chemistry and immunochemistry laboratory automation solution.

3.2 The solution shall include:

· Clinical Chemistry analyzers integrated with Immunochemistry analyzers

· Total Laboratory Automation (TLA) track system

· Middleware and data management systems

· Reagents, calibrators, controls, supplies, and consumables

· Hardware, software, and operating system support

· Installation and system validation

· Preventive maintenance and repair services

· End-user and administrator training

· Technical and applications support

3.3 All work shall comply with:

· Food and Drug Administration (FDA) requirements

· College of American Pathologists (CAP) standards

· Clinical Laboratory Improvement Act (CLIA) requirements

· VA policies and cybersecurity requirements

· Manufacturer specifications

· Applicable Federal, State, and local regulations

4. Place of Performance

4.1. Services and equipment will be provided at the following locations:

· C.W. Bill Young VA Medical Center (CWBYVAMC) 10,000 Bay Pines Blvd Bld.100 – Room 2B-110 Bay Pines, FL 33744

· Lee County VA Healthcare Center (LCHCC) 2489 Diplomat Parkway East Room 1B-106 Cape Coral, FL 33909

NOTE: Additional performance locations may be added during the contract ordering period only through a bilateral contract modification executed by the Contracting Officer and the Contractor. Any such modification shall address, as applicable, changes to estimated quantities, CPRR unit pricing, equipment and automation requirements, implementation and transition requirements, and the IDIQ contract maximum. No additional location shall be added, and no performance at an additional location shall commence, without an executed bilateral contract modification.

5. REQUIRED TEST MENU (referred to as Attachment A): Comment by Rodriguez, Moneque L.: Required? Comment by Tran, Han: yes Refer to Attachment A for a list of tests and estimated annual volumes by laboratory. Test menu requirement may be met by using alternate FDA approved reagents adapted to the proposed analytical solution for no more than 5 tests. Annual test volumes provided with this contract are based upon prior history and are not a guaranteed minimum. New tests within the scope of the contract may be added to the test menu. The Contractor shall provide all reagents and materials required for test validation, with associated costs included in the applicable CPRR unit price. Tests outside the existing scope or established pricing shall require a bilateral contract modification.

The Contractor shall perform specimen integrity checks/indices on all applicable specimens, with associated costs included in the CPRR unit price.

If, at any time during the contract period, the Contractor is unable to perform a test included in the contract and the Government is required to obtain that test from another source, the Contractor shall reimburse the Government for all additional costs incurred for the referral testing, including any associated processing and shipping costs.

Note: Volumes listed are estimated workload based on historical data and are not guaranteed minimums.

Note: All bolded and italicized are considered STAT (immediate) tests

Estimated Annual Quantity

Annual Volume

LCHCC

Estimated Annual Volume

6. Requirements

6.1 General Requirements

· The contractor is required to furnish all of the following to all locations defined within the contract (as a single price, CPRR):

· Instrumentation hardware and software to include but not limited to analyzers, automation track system, operating system, printers, monitor screens, Uninterruptible Power Supply (UPS), etc.

· All Reagents, Calibrators, and Quality Control materials vendor-manufactured Quality Control (QC) materials only for the proposed system. The Government will procure third-party QC materials separately.

· All consumables and user-defined replacement parts necessary to operate the contractor's equipment, including secondary, aliquot tubes.

· Upgrades to and maintenance of hardware and software necessary to fulfill the test requirements and allow for continuous operation.

· On- and Off-site training for end users and key operators.

· Delivery and installation of equipment at no additional charge as well as removal of test system and return shipping costs at end of contract.

· Equipment and assay installation and full validation of system hardware and software as well as assay performance studies (to include but not limited to assay correlations to existing instrumentation, carryover, linearity, dilution validation, precision, accuracy, reference range studies, and normal range studies).

· Complete system software verification, including initial rule build and validation, including but not limited to routing rules and auto-verification for the entire defined test menu. This applies to the initial test menu and any new assays added via modification of the contract throughout the life of the contract.

· Support for the modification to vendor-owned automation track system’s software with the addition of or modification to 3rd-party connections.

· Standard Operating Procedures (SOP) for all assays, maintenance tasks, and equipment operation shall be provided by the vendor.

6.2 CPRR pricing shall be based on the collective annual test volume for all testing locations (same price regardless of test location).

6.3 The VA Healthcare Network facilities will only pay for the patient test results reported to the patient’s medical record. There shall be no minimum monthly charge.

6.4 CPRR shall be based on a tiered volume with additional savings as testing volume increases. Failure to adequately charge for estimated cost on volume as disclosed will not incur additional charges. Inflated reagent estimates if not consumed will not be charged.

· Annual test volumes provided are based upon historical reported result data and are not guaranteed a minimum.

· New tests may be added as requested via contract modification as baseline cost per test (CPT) or reduced pricing on the cost per reportable result (CPRR) without instrumentation hardware and software or service costs added.

· All reagents for instrument verification and test method validation, per College of American Pathologists (CAP) and VA guidelines, are to be supplied by the contractor at no additional cost to the government.

· If at any time during the contract period, testing for the defined test menu is not available on this list, the Contractor shall provide, or reimburse the government, any additional costs associated with the procurement of another source of satisfactory test performance (i.e. reference laboratory, alternate testing instrument, etc.).

6.5 Space Allocations per Facility:

The proposed solution must fit within the allocated space using existing drains (all locations). The proposed automation solution shall be designed to support future expansion and integration without requiring significant modification to the laboratory footprint or core automation infrastructure.

· C.W. Bill Young VA Medical Center (allocated space must also include the Sysmex XN 9100 with 2- XN10, 2-XN20, 1-SP50, 1-BT50, and 1 DI60 TLA)

· Lee County VA Healthcare Center

7. Instrumentation Requirements

7.1 Integrated Chemistry-Immunochemistry System Requirements

· System shall have automation and front-loading capabilities.

· System shall prioritize automation. Site(s) with an automation line shall have both chemistry and immunoassay systems integrated and connected to the automation line. Site(s) without an automation line shall have chemistry and immunoassay systems connected and integrated.

· Be space efficient and can be installed within the existing floor space square footage with proper egress for safety. The equipment proposed must accommodate workflow to ensure easy access to other parts/departments of the laboratory

· Relocated equipment within the laboratory space must stay within the same room.

· “Affixed equipment” means equipment affixed or anchored to real property or requiring dismantlement for relocation.

· Secondary or backup analyzer(s) provided must be manufactured by the same Contractor receiving the award and use(s) the same reagents and test methodology for each test performed to allow for standardized test builds.

· Using third-party analyzer(s) to meet test menu requirements is not acceptable.

· Using third-party equipment for automation is acceptable.

· Third party open channel assay on contractors’ solution is acceptable.

· Contractor shall maintain an adequate replacement part inventory locally to minimize downtime associated with transporting parts to analyzer’s site. An adequate inventory would include parts that are known/could need to be changed frequently and should be kept either on-site or locally in a storage facility. Sufficient parts for routine maintenance to be kept onsite.

· If the integrated system requires a water system outside the Government-maintained water system, the Contractor to install and maintain an appropriately sized water system for the duration of the contract at the Contractor’s expense. The water system is to provide an acceptable quality and quantity of water to the analyzers according to the required specifications.

· Each analyzer should include an Uninterruptible Power Supply (UPS) with replacement when necessary.

· System shall be capable of handling primary tube sampling from collection tubes of various sizes and from various manufacturers.

· System shall be capable of sampling from tubes of various types, i.e. flat-bottom, round-bottom, sample cups, pour-off cups, false-bottom tubes, and tube inserts.

· System shall have ability to continuously load patient samples, reagents, quality control and/or calibrator materials during operation.

· System shall have ability to repeat and reflex test, auto-rerun and auto-dilute without user intervention.

· System shall have accurate capacity for monitoring reagent usage, maintain/store sufficient on-board supplies/reagents for 24 hours of patient testing on the combined platform, and provide reagent inventory upon request, in real time.

· System shall have RFID technology or similar/equivalent technology for rapid on-board reagent placement and tracking

· System shall have bidirectional interface capabilities.

· System shall have ability to perform serum indices, defined as the qualitative assessment of lipemia, icterus, and hemolysis.

· System shall have ability to detect fibrin or clots and short samples during sample aspiration.

· System shall have no requirement for sample pre-treatment. no offline sample pre-treatment requirement applies specifically to A1C testing. Sample pre-treatment may be permitted for other assays when required by the assay methodology and the manufacturer’s instructions for use.

· System shall have ability to generate Critical and/or abnormal result flags.

· System shall have ability to lock out/suppress reagent packs if there are QC failures.

· System shall have the capability to add/adapt commercially available reagents not produced by the Contractor.

· System shall have minimal carryover risk. Contract shall be responsible for completing carryover studies at installation and meeting CLIA guidelines for acceptable results.

· Calibration requirement frequency for all tests not to exceed once per 24 hours per instrument.

· Quality control testing requirement frequency for all tests not to exceed once per 24 hours per instrument. Quality Control Testing: The proposed system shall support less frequent quality control (QC) interval times for all tests, including electrolytes, to minimize the frequency of QC activities while maintaining appropriate analytical performance and continuity of laboratory operations.

· 95% of reagents shall be ready-to-use.

7.2 Chemistry Instrumentation Requirements

· Provide clinical chemistry analyzer(s) with sufficient capacity and throughput to meet the volume demands as defined in the Test Menu (Attachment A – Volume Estimates and Individual Test Pricing. Throughput criteria:

· At CWBYVAMC: minimum of 1000 tests per hour per instrument

· At LCHCC: minimum of 450 tests per hour per instrument

· Provide chemistry analyzers with standardized assay testing methodology to facilitate optimal workload distribution and backup capacities as specified in the equipment list.

· Shall have a minimum of 60 chemistry reagent test slots per instrument for CWY and 40 for Lee County.

· STAT Chemistry test results shall be available in 15 minutes from the time loaded on the analyzer to when results are available to maintain or improve current turn-around-time (TAT).

7.3 Immunochemistry Instrumentation Requirements

· Provide immunochemistry analyzer(s) with sufficient capacity and throughput to meet the volume demands as defined in the Test Menu (Attachment A – Volume Estimates and Individual Test Pricing. More tests per hour are preferred throughput to give room for instrument downtime-maintenance and equipment issues. Throughput criteria:

· At CWBYVAMC: minimum approximately 250 tests per hour per instrument

· At LCHCC: minimum approximately of 100 tests per hour per instrument

· Provide immunochemistry analyzers with standardized assay testing methodology to facilitate optimal workload distribution and backup capacities as specified in the equipment list.

· Analyzer shall have ability to aspirate the sample and release the tube, so additional tests can be run without delays.

· Cardiac STAT immunoassay incubation times shall not to exceed 10 minutes to meet chest pain center accreditation requirements and maintain or improve current turnaround time (TAT). Cardiac STAT Immunoassays: Cardiac STAT immunoassays shall provide quick incubation times that support Chest Pain Center accreditation requirements and maintain or improve the Government’s current turnaround time (TAT). Incubation time shall be considered in conjunction with the assay methodology and its ability to support timely availability of patient results.

· Routine immunoassay incubation times not to exceed 30 minutes to maintain or improve current TAT. For purposes of this requirement, “routine immunoassay” refers to immunoassay tests that are not commonly ordered as STAT and are not associated with an immediate or life-threatening clinical need. Examples of routine immunoassays include Vitamin B12, Vitamin D, Folate, PSA, and TSH.

· Analyzer shall have proven solution to mitigate carryover.

· A Troponin test which meets the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) definition of high sensitivity.

· High/Ultra-sensitive reagent-based assay shall be utilized to alleviate interferences Troponin Testing: The proposed system shall provide a high-sensitivity Troponin assay or equivalent assay capability that meets the applicable performance requirements specified in the solicitation and provides appropriate analytical sensitivity, accuracy, and reliability.

· State carryover claim and design solutions to mitigate carryover.

· Analyzer shall have ability to duplicate repeat infectious disease testing without operator intervention.

7.4 Power for Chemistry and Immunochemistry Instrumentation

· Individual components require no more than 50 amps, 110V or 220V. It is acceptable for peripheral equipment such as the monitor, computer, and printer, to be plugged into separate outlets or UPS.

· Installed within the existing power capability that exists for each laboratory, regarding both emergency and normal power.

7.5 Automation Requirements:

· Must provide evidence that the proposed solution can meet the space requirements. The CWBYVAMC automation system shall include an FDA-cleared interface to the Sysmex-9100 system.

· Shall have capacity to add automation connectivity for future requirements during the term of the delivery order/s. Any additions will be negotiated and require the signature of the CO and delivery order/s contract holder.

· Shall have capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and generating test volumes for invoice purposes.

· System Manager — receives specimen and records time, directs the scheduling, routing, and tracking of specimen carriers on the conveyor system from loading to final disposition. The information system component of this automation system shall be able to communicate with Lab Information System (LIS) for ordering information to be sent from LIS to the System manager and shall include but not be limited to: order code or name, tube type, accession number, container ID, and receipt date and time.

· Non-linear configuration of conveyor system for transportation of specimens to analyzers for optimal space utilization in lab and minimal disruption of current workflow and space. Pre/post analytical processors shall fit within currently allocated space.

· Sorter/Outlet station — sorts specimen tubes/aliquots into appropriate racks/targets based on the tests to be done (includes off-line instrument, reference lab or manual procedure by preselected rules) and archives specimens. Automated delivery and organization of specimens to outlet station based on bar-coded information.

· Refrigerator storage —

· Minimum storage capacity of 20,000 specimens

· Maximum heights not to exceed 95 inches

· Support automated specimen disposal rules

· Support specimens by defined criteria for disciplines not connected to the track, including specimens being sent to the reference laboratory.

· CWBYVAMC shall have a minimum of two (2) automation centrifuges capable of handling different tube sizes simultaneously and have adjustable time and RPM settings. Centrifuges shall have ability to produce sufficient separation of serum or plasma from its cellular constituents.

· Process at least 350 tubes per hour

· Automated placement of specimens into and removal from centrifuges with minimum loading and unloading times for maximum productivity.

· CWBYVAMC shall have an aliquoter for offline testing/sendouts.

· Ability to make barcode-labeled aliquot tubes that mirror the primary tube labeling for offline processing.

· Shall have the decapper/recapper/sealer system in an enclosed environment to prevent distribution of bio-hazardous aerosols.

· Decapper shall have the ability to remove different cap types, e.g. systems own caps, hemogard, screw caps, and rubber stoppers. This is necessary to maintain employee safety by reducing the exposure to body fluids and maintain workflow and turnaround time.

· Automation system shall have the ability to process 99% all of chemistry specimens, including whole blood and urine through the automation system.

· Contractor shall provide and install a suitable compressed air system sufficient for the automation system if needed.

7.6 System Data Management Requirements:

· A bi-directional bar-coded computer interface system compatible with the current VA LIS. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system CPRS/VistA.

· Capability to establish a remote connection for the purpose of instrument troubleshooting, reagent management, software updates, and delivering test volumes for invoice generation.

· HaveISA/MOU/ERA established with the VA OI&T (Office of Information and Technology) to allow for the implementation of remote diagnostics connectivity. All connectivity hardware and installation to be provided by the Contractor.

· Minimum of 25 thin client middleware licenses for Bay Pines VAHCS laboratories.

· Software management features with capability to prepare data for auto validation prior to host transmission.

· Sufficient data storage for 2 years of workload data and immediate access to more than 5,000 patient records per day, including instrument identification (houses PHI and PII).

· All equipment shall be compatible or have the ability to act as a pass-through to Data Innovations Instrument Manager (DI) for auto verification of patient results.

· Ability to manage rules for optimal specimen handling with ability to send automated comments to patient host records.

· Ability to perform repeat testing or add-on testing through Data Management system.

· Compatible with external Government Contractor software Unity Real Time Quality Control (QC) program.

· Updates to Data Management software are provided at no additional charge when they become available.

· Provide license(s) and hardware if needed for Data Innovations or other middleware at no additional charge to the VA.

· All software and software licenses, interfaces, and hardware (e.g. servers, printers, monitors, UPS, etc.) shall be included with cost of hardware required disclosed for removal if needed.

· The contractor is responsible for complete system software verification, including initial rule build and validation, at installation and anytime new assays added via modification of contract throughout the life of the contract.

· The contractor is responsible for assisting the Government with automation track operating system modifications (e.g. routing rules) when 3rd party connection is added/modified. The Government agrees to assume the cost of connection license for any Government-owned/contracted equipment at the Government’s request.

7.7 Additional Requirements

· The contractor must provide all monitors (minimum 32”) for the contractor’s data management system/automation track system as applicable.

· The system shall include documents providing information on:

· Electrical specifications

· Water consumption specifications

· Heat output specifications

· Noise level specifications

· The system must have the ability to print patient test results / quality control results on a paper non-network connected printer in the event of a complete hospital network outage.

· The contractor must provide all printers, including all components for printer functionality and printing (excluding paper)

· The analyzer system must have the capability to produce a chartable patient report, including the following mandatory characteristics:

· Facility Name

· Facility Address

· Facility Laboratory Medical Director

· Laboratory CLIA Number

· Test Result

· Test Normal Reference Range

· Test Unit of Measure

· Test Critical Values / Flags

7.8 Upgrades / Replacement of Equipment within the TLA System Request for upgrades or replacement hardware/software, due to workload increase, excessive instrumentation failures will be evaluated as needed or at least annually with communication to the Contractor for modification of the contract. A high incidence of such problems with any equipment/analyzer or assay within the test menu supplied may indicate probable non-compliance with the terms of this contract and will entitle the government to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily.

· “Downtime” is defined as any time the equipment is not available for patient testing due to malfunction, unacceptable quality control, software system errors, or hardware failures. This includes time used for end-user troubleshooting, conversations with technical support or on-site engineer repair/support.

· Standard acceptable performance for the life of the contract is defined as a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification without prolonged downtime (>4 hours) per instance more than 3 times within 30 days, or more than 10 instances of downtime (of any length of time) within 30 days. In the event the equipment or an assay does not meet the standard acceptable performance for 30 consecutive days, the Government will notify the contractor of the ongoing unacceptable performance, and the performance will be monitored for an addition 90 consecutive days. If after 120 calendar days from the initial date of unacceptability, the vendor does not resolve the performance concerns to meet the Government’s expectations, the Government, through the Contracting Officer, may request a replacement of the equipment / assay or terminate the order upon mutual agreement.

· Removal of the existing instrument by the contractor shall be performed within 30 days following the acceptance of replacement equipment without additional charge to the government.

· Enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

· The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the Government.

7.9 Adding New Analyzers to the Total Lab Automation System

Additional laboratory equipment or analyzers may be connected to the Total Laboratory Automation (TLA) system through a bilateral contract modification. The modification shall establish, as applicable, any additional requirements, pricing, and implementation responsibilities. Following execution of the modification, the Contractor shall provide the technical support and application specialist(s) necessary for installation, connection, and validation of the additional equipment or analyzers.

Validation of the TLA system shall be performed in accordance with Government-defined guidelines and acceptance criteria. The Contracting Officer’s Representative (COR) shall review all installation and validation documentation for technical acceptance.

Enhancements or upgrades to Contractor-provided equipment that are necessary to maintain the required functionality and performance of the TLA system shall be delivered and installed by the Contractor within 60 days. The costs of such enhancements or upgrades shall be included in the established CPRR pricing.

7.10 Adding New Assays to the Existing Analyzers

Additional assays may be added to the existing test menu through a bilateral contract modification. The modification shall establish, as applicable, any additional requirements, CPRR pricing, and implementation responsibilities. Following execution of the modification, the Contractor shall install and validate the assay in accordance with Section 6, General Requirements for a CPRR Contract. The assay shall be available for Government acceptance within 30 days after execution of the modification.

8. Installation/Implementation

8.1 PHASE-IN/PHASE OUT REQUIREMENT - Due to the time required to implement the requirements of this contract, including equipment installation, system integration, validation, training, and transition activities, a phase-in/phase-out period is required to ensure continuity of laboratory operations and prevent disruption to patient care.

8.2 Phase-in requirements: The implementation of the requirements described in this solicitation shall be completed no later than 180 days or based on the mutually agreed upon timeline by the Contractor and Government after award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e., construction/ remodeling of facilities). Upon award, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be 90 days from the date of award through 120 days or based on the mutually agreed-upon timeline by the Contractor and VA. This requirement includes the implementation of auto verification and the transmission of QC data to an external real-time QC service. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government.

· The new Contractor must be able to coordinate with the laboratory and install the new equipment while the current Contractor’s equipment is still in operation in order to prevent any lapse of service for laboratory testing.

· At the end of 120 days from award of the Contract, the awarded Contractor has full and sole responsibility for services under the awarded delivery order/s.

8.3 Phase-out Requirements: During the phase-out period, the incumbent contractor shall be fully responsible for all work performed under this Statement of Work (SOW). Up to 180 calendar day phase out period may be required. The incumbent contractor shall cooperate fully to permit an orderly changeover of laboratory workload. The incumbent contractor shall allow the new contractor and government personnel access on a non-interference basis, to observe the day-to-day operations and to become familiar with the work requirements and procedures.

8.4 Within one week from the date of award, the CO, CORs and the Contractor will hold a kickoff meeting to discuss implementation.

8.5 Acceptance and Performance: This paragraph establishes a standard of quality performance that is to be met before any equipment listed on the delivery order/s 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 begins on the installation date. Acceptance will occur once the analyzers/equipment have met the standard performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as proposed in the contract at an effectiveness level of 90% or more.

8.6 Start-Up Reagents: The Contractor provides all reagents, calibrators, controls, consumable items, disposable items, parts, accessories, and any other items included on the list of supplies defined in the contract and required to establish instruments for operation for performance of acceptance testing. The Contractor performs, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, carryover studies, verification of reference interval, dilution validations, and determination of sensitivity and specificity at no cost to the Government.

8.7 In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests continues on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

8.8 If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the Government may request a replacement or terminate the delivery order/s. (The Contractor will receive revenue for tests reported during the 90-day acceptance period.).

8.9 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 the period of time when any analyzer in the system is inoperable due to equipment failure. Downtime for each incident starts 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 analyzer(s) is returned to the Government in proper operating condition.

8.10 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work required begins as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours will be used when in excess of the minimum of 100 hours.

8.11 The Government will maintain daily records to satisfy the requirements of this paragraph and notifies the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime will be measured in hours and whole minutes.

9. Service and Maintenance Contractor provides equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, covered under the delivery order/s award, and UPS.

9.1 Maintenance plan: Contractor provides manufacturer’s daily, weekly, monthly, quarterly and periodic maintenance plan, outlining time required for hands on and automated tasks.

9.2 Support Services: Contractor provides telephone assistance 24-hours/day, 365 days per year with a call back response of 1 hour. Following determination that service is required, technical on–site support provided under the terms of the contract and provided for emergency repairs 365 days per year within twenty-four (24) hours of the time of notification of the malfunction for medical center lab(s) - CWBYVAMC lab. For Community Based Outpatient Clinic (CBOC) lab(s) – LCHCC lab, during normal operating hours, within twenty-four (24) hours of the time of notification of the malfunction. If both primary and backup analyzers are not able to perform a test listed as STAT, Contractor shall have defined, approved contingency plan(s) to ensure continuation of testing. Contractor provides maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The Government will provide the Contractor access to the equipment to perform maintenance service according to the maintenance and service terms.

9.3 Incident/ Service Reports: Contractor to furnish a malfunction report on the instrument upon completion of each repair call. The report includes, at a minimum, the following: (a) date and time notified; (b) date and time of arrival; (c) serial number, type and model number(s) of equipment; (d) time spent for repair; (e) description of malfunction and repair; and (f) proof of repair that includes documentation of quality control being performed and within range, as applicable. Contractor shall notify the lab supervisor/management if repair is significant enough to require calibration and/or validation following the repair. Contractor shall perform all calibration and/or validation as applicable for the instrument to be ready for patient testing.

9.4 Daily maintenance: Instrumentation requires minimal hands-on daily maintenance.

9.5 Preventative Maintenance: Contractor shall provide regular, scheduled maintenance coordinated with the lab supervisor/management to assure the continued reliable operation of the equipment. These preventive maintenance visits are of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.

9.6 Emergency Repair: Emergency repairs to be performed after notification that the equipment is inoperative. Contractor shall provide the Government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. Contractor shall perform emergency repair service within 24 hours of time of notification of the malfunction. Contractor shall provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the Contractor.

9.7 Maintenance Support: Service repair person locally based within the geographical area. For purposes of this requirement, “locally based” means that qualified service repair personnel must be located within approximately a 90-minute drive time of the applicable facility. This proximity is required to support an on-site response within two (2) hours of a service request.

There is no specific mileage or residency requirement; however, the Contractor must maintain sufficient local service coverage to consistently meet the required two-hour response time.

9.8 Maintenance Credit for Equipment Malfunction: If a machine remains inoperative due to a malfunction through no fault or negligence of the Government for more than 24 hours, the Contractor shall be assessed damages at the rate of 1/30 of the preceding average three-month CPRR billings times the total number of days certified as downtime with each incident starts from the time the user makes a bona fide attempt to contact the Contractor's designated representative at the prearranged contact point until the machine is returned to good operating order less any non-contracted maintenance (emergency repairs) days.

9.9 Replacement of Laboratory Equipment: During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the Government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the Contractor.

9.10 Failure Mean Time Disclosure: Contractor states the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Contractor shall provide redundant systems to eliminate need of emergency backup equipment. An acceptable redundant solution requires duplicate instruments with identical test menu capabilities. The intent is to ensure continuity of laboratory operations when one instrument is out of service due to scheduled maintenance, repair, or an unexpected equipment issue. An integrated backup capability within a single instrument or platform does not satisfy this requirement unless it provides the same level of operational redundancy as a separate duplicate instrument. The laboratory must be able to continue performing the required test menu when one instrument is unavailable.

9.11 Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls, will be evaluated as needed/annually with communication to the Contractor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the Contractor performed within 60 days after request.

9.12 FDA Approved Instruments and Methods: Only instruments which are FDA approved will be considered and shall be operational and interface with VA Laboratory Computer systems and upgrades. Test methods shall be FDA approved with limited recalls due to product failures. This shall be a "turn-key" system.

9.13 Operator Procedure Manuals: One Operator’s manual along with CLSI compliant procedures shall be furnished for each instrument model supplied per site.

10. Service and Technical Support The Contractor shall provide full service on-site technical support for all vendor-owned equipment, including the automation track system, to keep the equipment in good operating condition and subject to security regulations.

On-Site Support Coverage:

· CWBYVAMC

· Twenty-four (24) hours per day

· Seven (7) days per week

· Including Federal holidays

· LCHCC

· Monday through Friday

· Eight (8) hours per day

· 8:00 AM to 4:00 PM

11. Requirements While Working at the Facilities

· The Contractor’s employees approved by the COR will wear visible identification at all times while on the premises of the facilities within the NCO. Identification will include but not be limited to a company identification card, including the company name, employee name, title, and a photograph of the employee. Contractor employees will maintain a professional appearance commensurate to their industry.

· It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. This will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

· Any interior or exterior doors that are unlocked to gain access are to be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices will be locked immediately upon entry or exit. At no time will the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

· Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “Contractor” badge prior to contacting the COR. The Contractor's staff will also be required to sign in and out each day at a designated location determined by the COR. Some sites may require contractor staff to register in a Contractor’s system.

· Smoking is prohibited inside any buildings at the facilities.

· Possession of weapons is prohibited. Enclosed containers, including tool kits, are subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

· The Contractor will not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor is responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government is not obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

· Contractor personnel will follow all local infection control measures.

12. Ownership of Equipment Title to the equipment remains with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor will accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order/s, at termination and/or replacement of equipment, will remove the equipment at the expense of the Contractor. The Contractor will disconnect the analyzer (gas, water, air, etc.) and will be responsible for all packing and shipping required to remove the analyzer. The hard drive will remain at the VA.

13. Equipment Removal Following the expiration of this contract, the Contractor will remove all equipment within 30 days after notification of the completion of new Contractor’s equipment installation including cross over studies and approval for use for patient testing.

14. DELIVERY, PERFORMANCE, INSPECTION AND ACCEPTANCE:

14.1 General:

· The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The Government has the right to test all services ordered under the contract at all times and places throughout the term of the contract Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.

· The Government reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance.

· Returned goods: The Government is responsible for inspecting all products shipped hereunder and will give the Contractor written notice of rejection within…