Attachment A - Statement of Work - Osmometer.docx

STATEMENT OF WORK

SOUTHERN ARIZONA VA HEALTH CARE SYSTEM (VA TUCSON)

PATHOLOGY AND LABORATORY MEDICINE SERVICES

OSMOMETER

SECTION A – INTRODUCTION AND SCOPE

1. The Department of Veterans Affairs, Southern Arizona VA Health Care System (VA Tucson), Pathology and Laboratory Medicine Services has a requirement to purchase 2 osmometers that shall fully support the scope of operations (minimal requirements). The instrument shall be capable of simultaneously performing the complete profile as described below, meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

1.1. Clinical Laboratory Osmometer Analyzer – Automated system for the handling and accurate analysis, data review, and reporting of human osmolality test results. The osmometer shall use freezing point depression to determine the osmolality of aqueous solutions (urine and serum). The analyzer offered by the contractor shall fully support the estimated annual site volume listed on the schedule.

1.2. Equipment: All equipment delivered to the participating medical center and shall be new, state of the art, and not recertified nor refurbished.

1.3. Industry Standards: Unless otherwise stated, all equipment shall be held up to current industry standards for such equipment is present in the current marketplace for Clinical osmometer equipment, supplies and related services.

1.4. Contractor must follow all applicable state, federal and local laws, and regulations related to laboratory testing.

2. Period of Performance: The period of performance of the resulting contract shall be for a base year plus 4 option years where the Osmometers shall be acquired as a purchase (with a minimum of one-year warranty) and service/maintenance, licenses, and supplies shall be renewed on an annual basis.

3. Participating Facility(ies):

Department of Veterans Affairs Southern Arizona VA Healthcare System (VA Tucson) Pathology and Laboratory Medicine Services 3601 S 6th Ave Tucson, AZ 85723

SECTION B – MINIMUM SYSTEM REQUIREMENTS / SALIENT CHARACTERISTICS

The contractor shall provide osmolality testing equipment that meets all the following requirements:

1. Instrumentation Requirements:

1.1. The ability to use a variety of primary tube sizes.

1.2. Performs multisampling of specimens using the same primary tube.

1.3. Results shall be fast and accurate.

1.4. Interface with SAVAHCS lab information system (LIS) for seamless transmission of test results to LIS.

1.5. The osmometer shall have built-in quality control software that includes statistical monitoring of daily QC, ability to set custom ranges, set action limits for out-of-range QC and a supervisor menu with password protection and lockout features.

1.6. The osmometer shall have a measuring range of 0 – 2000 mOsm/kg H2O, and run with national standards for accuracy and precision

1.7. Calibrations are to be stable by minimum CLIA specifications.

2. Barcoding Requirements:

2.1. Equipment must be able to support multiple barcode formats (Code 39, Code 128)

2.2. Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology.

3. Printers and Other Support Items (Support Items):

3.1. Each analyzer must have a compatible dot-matrix printer available for purchase.

3.2. Printer paper rolls for dot-matrix printer shall be available for purchase.

4. Software, Connectivity and Conformance Standards:

4.1. Instrument Software – Internal testing instrumentation software that provides/maintains the following:

4.1.1. Ability to monitor instrument performance.

4.1.2. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records.

4.1.3. Capability to record, store and print the following information:

4.1.3.1. Quality control, calibration, and instrument maintenance information.

4.1.3.2. Patient demographic information and specimen results.

4.1.4. Ability to retransmit patient records to the Laboratory Information System (including contractor provided middleware) in case of interface outage.

4.2. Interface

4.2.1. The Contractor shall provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

4.2.2. The vendor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500). Any wireless equipment must be FIPS 140-2 compliant with certificate of compliance.

4.2.3. The Contractor supplies responses to required documents to add systems to the VA network including but not limited to the VA Form 6550, Ports Protocols Services, MSD2, network Topological diagram and Equipment Inventory hardware/software list.

4.2.4. If there are software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA Laboratory Interface Middleware.

4.2.5. If the Operating System (OS) and/or Firmware are updated or the OS reaches end of life during the contract period, the vendor shall update OS and/or Firmware at no additional cost. Additionally, if the hardware requires an update or replacement to support the OS/Firmware, the vendor shall update/provide the needed hardware at no additional cost.

4.2.6. Sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.

4.2.7. Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation.

4.2.8. Ability to retransmit patient records to universal interface system in case of interface outage.

4.2.9. Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing).

4.2.10. Technology must interface to VA licensed Data Innovations Instrument Manager sending all appropriate information to complete auto verification rules processing within the VA licensed IM. Preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA licensed DI IM.

4.3. Connectivity and Conformance

4.3.1. Contractor shall meet VA OI&T information security requirements IAW VA Directive 6500.

4.3.2. Contractor shall provide remote monitoring and support of the osmometer system while the manufacturer’s warranty is active. Contractor shall use remote monitoring to prevent instrument or testing issues, when possible, in addition to troubleshooting and support. The Contractor shall provide all hardware and software to implement the remote support system.

4.3.3. The osmometers system’s operating software version must be approved for use on the VA network (Windows 10 and Server 2012/2016).

4.3.4. The osmometer system must be capable of connecting to an HL7 interface and must comply with the VHA Lab HL7 Interface Specifications Document.

· https://www.va.gov/vdl/application.asp?appid=71

· https://www.va.gov/vdl/application.asp?appid=75

4.3.5. Any software and hardware solutions supplied and installed on VA workstations by the contractor must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must appear on a TRM that is within 2 lifecycles of the most recent TRM approved version. For software or hardware solutions that do not meet these requirements at the time of contract award, Contractor shall obtain the required TRM approval without impacting installation timeframes.

· https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx

SECTION C – STATEMENT OF WORK

1. Support Features

1.1. Commercial marketing.

The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

1.2. Service Maintenance / Warranty

1.2.1. The Contractor shall be able to provide equipment repair and preventative maintenance on all primary instrumentation and ancillary equipment within the provided system(s) according to manufacturer specifications, and laboratory regulatory bodies, such as CLIA, CAP, VA National Enforcement Office, and TJC.

1.2.2. The contractor provides a technical assistance center which will be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of one (1) hour.

1.2.3. All equipment, including ancillary equipment, and repair service shall be provided Monday through Friday from 8:00a.m. to 4:00 p.m. local time. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. If one analyzer is down service converts to 24/7 to maintain all operations. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than 4 hours. Delivery of parts and equipment to fix instrumentation must be within the Preventative maintenance period and will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date or more frequently based on instruments’ performance.

1.2.4. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

· date and time notified

· date and time of arrival

· serial number, type and model number of equipment

· time spent on repair(s), and

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

2. Waste

2.1. The Contractor shall provide documentation demonstrating that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges Contractor provides in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to decide if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following:

2.1.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

2.1.2. Waste ignitability (Reference 40 CFR §261.21)

2.1.3. Waste corrosivity (Reference 40 CFR §261.22)

2.1.4. Waste reactivity (Reference 40 CFR §261.23)

2.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

2.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

2.1.7. Solid Waste (Reference 40 CFR §261.2)

2.1.8. Exclusions (Reference 40 CFR §261.4)

2.2. The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.3. Contractor shall provide a description of all wastes the equipment or process may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review.

2.4. The documentation the contractor provides will be used to work with the medical center, CBOCs, and the public or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system.

2.5. Ability to separate alcohol waste from other waste for appropriate environmental disposal.

3. Onsite Installation

3.1. Site preparation & electrical: Ensure a stable bench space with standard lab power supply (refer to user manual for specific voltage requirements).

3.2. Unpacking & placement: Certified technician will unpack the system, inspect for shipping damage, and position it in the designated lab area.

3.3. Connection & setup: This includes hooking up power, verifying grounding and ESD precautions, connecting any laboratory information system (LIS) or network interfaces, and installing any optional accessories like barcode scanners or printers.

3.4. Initial system configuration: Configure the instrument settings such as date, language, user accounts, calibrator lot numbers, and quality control parameters.

4. Validations & Calibration

4.1. Factory calibration: The instrument arrives factory-calibrated and ready for clinical use.

4.2. Linearity validation: Using the provided Osmolality Linearity Set, the technician will verify the instrument’s range accuracy (e.g., 0–2000 mOsm/kg), following CLSI or CAP standards.

4.3. Daily QC & calibration checks: Perform daily checks with NIST-traceable reference solutions and biologically relevant controls. Any out-of-range values will trigger recalibration and re-verification.

4.4. Performance evaluation: Conduct a short workflow using patient-like samples, documenting precision, and accuracy within specified limits—leveraging built-in diagnostics and run logs.

5. Patient Comparison Studies (Method Comparison)

5.1. Sample requirement: A minimum of 20 patient samples will be run side by side on the current osmometer instrument and the new osmometer instrument.

5.2. Sample selection: Samples will be selected to represent a clinically relevant range of osmolality values (low, normal, and high), ensuring adequate coverage for method comparison.

5.3. Testing procedure: Each sample will be measured on both instruments under identical handling and environmental conditions. Replicates may be performed if required by internal VA or CAP/CLSI validation standards.

5.4. Acceptance criteria: All comparison results must meet established validation criteria, typically including:

5.4.1. Correlation within acceptable limits (e.g., slope, intercept, R² based on CLSI EP09-A3 standards)

5.4.2. Bias within allowable total error

5.4.3. No statistically significant differences that would affect clinical interpretation

5.5. Documentation: Full comparison data (raw values, statistics, graphs, and summary) will be provided and must pass all validation criteria before the Osmometer is placed into clinical service.

5.6. Vendor support: The vendor technician will assist with workflow, instrument readiness, and troubleshooting during the comparison process, but the clinical lab will perform and own the final validation analysis as required by VA and regulatory standards.

6. User Training

6.1. Training shall be conducted on site to ensure hands-on instruction and optimal familiarity with the instrument.

6.2. The vendor shall provide training for two designated “super users.”

6.3. Group training sessions shall be provided up to 2 hours in duration, allowing adequate time for operational instruction, maintenance procedures, quality control workflows, and user questions.

6.4. The exact structure and flow of the training may be determined by the trainer; however, the minimum time requirement must be met.

6.5. Training must include hands-on demonstration of routine operation, QC management, maintenance tasks, and troubleshooting procedures.

6.6. User interface and software navigation: In-person training on the touchscreen interface, menu navigation, test initiation, and data handling.

6.7. Sample handling & operation: Instruction on continuous loading of primary tubes, STAT sample workflow, and on-screen guided maintenance animations.

6.8. Quality control management: Training covers daily QC routines, Levey-Jennings chart interpretation, and troubleshooting QC failures.

6.9. Maintenance & diagnostics: Technicians will demonstrate daily/end-of-shift steps, 500-test maintenance, and the use of diagnostics menus (e.g., A/D converter, sensors, barcode readers, touchscreen/calibration checks).

6.10. Data management & connectivity: Guidance on exporting results (USB, LIS connectivity) and enrolling device participation in remote peer group programs.

7. Packaging & Marking

7.1. Packaging

All equipment shall be adequately packaged to prevent damage during shipping, handling, and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

7.2. Marking

All items shall be marked clearly with the Contract Number, Obligation number, and delivery location within the facility, i.e., Pathology & Laboratory Services.

8. Deliveries & Performance

8.1. Delivery: The Contractor shall deliver all osmometer analyzers to SAVAHCS.

8.1.1. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Point of Contact (POC) will notify the Contractor when delivery locations have been changed.

8.1.2. All deliveries shall be made from 8:00 a.m. to 4:00 p.m., Monday through Friday, and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete contract number, purchase order number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Standard orders shall be delivered no more than 30 working days after receipt or placement of order.