2.1 Sample - Scope of Work - UN3000 (002).docx

Scope of Work

1. LANGUAGE

1.1. INTENT: It is the intent of the [SYSMEX for NMRTC Bremerton] to establish a contract for Automated Urinalysis Instrumentation. The contract shall be a firm fixed monthly payment, Clinical Laboratory Analyzers.

1.2. PRICES AND TERMS: Pricing is based on the AVERAGE monthly test volume. The Government estimates a volume of 14,600 reportable per month on the Urine Chemistry Analyzer and 10,950 reportable per month on the Urine Sediment Analysis.

1.3. TERM OF AGREEMENT: This will be a single award, firm-fixed price with one base year, and two year options. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time there is a need to be a change in the contract.

2. DESCRIPTION/SPECIFICATIONS

2.1. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the performance work statement. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meet 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).

2.1.2. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables unless documented as excluded and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

2.1.3. Special handling for emergency orders of supplies: 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 a verbal order 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 requests for emergency supply delivery are 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.

2.2. DEFINITIONS:

2.2.1. Firm Fixed Monthly Payment - The patient reportable results price shall include:

2.2.2. (1) 5-year equipment use, (2) 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 patient reportable result (unless designated as excluded. (3) all necessary maintenance to keep the equipment in good operating condition (his element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

2.2.3. Parameter definitions

2.2.3.1. Automated Urine Macroscopic – Chemical analysis of urine to include color, clarity, specific gravity, pH and the presence/absence of leukocytes esterase, nitrites, total protein, glucose, blood/hemoglobin, ketone, urobilinogen, and bilirubin.

2.2.3.2. Automated Sediment/Microscopic Analysis- Analysis to determine the presence/absence of sediment constituents, such as but not limited to red blood cells, white blood cells, casts, crystals, bacteria, etc. Instrument must be able to display particle images when needed to provide high confidence in the classification of such elements.

2.3. GENERAL REQUIREMENTS:

2.3.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this solicitation.

2.3.2. Contractor shall provide quality control material at a minimum of two levels: normal and elevated/abnormal levels.

2.3.3. Significant physical, functional and performance characteristics- The instrumentation offered shall have the following:

2.3.3.1. Technology that assays urine chemistry and urine sediment/microscopic testing with Fluorescent Flow cytometry technology and digital imaging and a reliable chemistry back up analyzer.

2.3.3.2. Electrical compatibility 110 volts /220 volts.

2.3.3.3. Cart, Wagon, or Table for analyzers to sit and capable of housing reagents for the primary analyzers.

2.3.3.4. Urinalysis analyzer with identical bench top back up chemistry analyzer which ensures standardized test results and excellent correlation

2.3.3.5. Urine Chemistry analyzers should have RFID or similar labelled test strips with auto humidity checks to ensure strip integrity.

2.3.3.6. Urine Chemistry analyzers should have automatic color correction, thereby reducing potential for false positives.

2.3.3.7. UA analyzer with digital imaging which yields microscope- quality images with accurate sediment classification and cell identification for fewer screen review.

2.3.3.8. Decreased need to do manual microscopy for confirmation of formed elements. i.e., presence of bacteria, yeast cells and crystals.

2.3.3.9. Random access with walkaway shutdown, restart capabilities and continuous analyses.

2.3.3.10. Utilize Fluorescent Flow Cytometry methodology in identifying and quantifying cells. Utilizing side scatter detection technology to differentiate similarly sized crystals and RBC.

2.3.3.11. Reduced carryover with user adjustable carryover rinse cycle settings to eliminate interference.

2.3.3.12. Analytical Measurement Range for WBC of greater than 5,000/µL and greater than 10,000/µL for RBC to reduce dilution requirements and operator intervention.

2.3.3.13. On-Board Warmer that dissipates urates and phosphate material thus eliminating an additional step to reduce amorphous interference. This will help tremendously in analyzing samples collected and stored before analysis.

2.3.3.14. Provide calibration and assisted calibration verification and set up reference ranges.

2.3.3.15. Ready to use reagents with good stability up to 14 days.

2.3.3.16. Easily standardized with accurate particle differentiation, bacteria quantification, and enhanced detection down to <0.5 um.

2.3.3.17. Minimal maintenance <30 minutes with walkaway capability and minimize staff hands-on and free technologists for more critical tasks.

2.3.3.18. Be able to print results and/or interface to Cerner Genesis.

2.3.3.19. Data Innovations interface compatible.

2.3.3.20. Cost effective, Safe, Easy to use and labor saving.

2.3.3.21. Assays FDA approved.

2.3.3.22. Precision when compared with other laboratory performances on proficiency surveys.

2.3.3.23. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

2.3.3.24. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

2.3.3.25. Service Requirements

2.3.3.25.1. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within two weeks of the scheduled due date.

2.3.3.25.2. A technical assistance center shall be available by telephone 24 hours per day, seven days per week with a maximum call back response time of 2.0hour(s).

2.3.3.25.3. Equipment repair service shall be provided during core business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and laboratory personnel.

2.3.3.25.4. Equipment repair response time shall be no more than two hours.

2.3.3.25.5. 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:

2.3.3.25.5.1. Date and Time Notified

2.3.3.25.5.2. Date and Time of Arrival

2.3.3.25.5.3. Serial Number, Type and Model Number of Equipment

2.3.3.25.5.4. Time spent for Repair, and

2.3.3.25.5.5. Proof of Repair that includes documentation of a sample run of quality control verifying acceptable performance.

2.3.3.25.6. Each notification for an emergency repair service call shall be treated as a separate and new service call.

2.3.3.26. Upgrades - 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. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability.

2.3.3.27. 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.

2.3.3.28. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

2.3.3.29. Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges.

2.3.3.29.1. The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices.

2.3.3.30. The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

2.3.3.31. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. 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.

2.3.3.31.1. Upon award of contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.3.3.31.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all 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. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.

2.3.3.31.3. 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.

2.3.4. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order 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 90% or more.

2.3.4.1. If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

2.3.4.2. 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 tests reported during the 90-day acceptance period.)

2.3.4.3. 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.

2.3.4.4. 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.

2.3.4.5. 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.

2.3.4.6. 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 COR 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 90% in each month of the term of the agreement for equipment.

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

2.3.6. 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 order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

2.3.7. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

2.3.8. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.

2.3.9. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

2.3.10. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

2.3.10.1. Contractor must accept the system without the drive.

2.3.10.2. VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

2.3.10.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

2.3.11. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then.

2.3.11.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2.3.11.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order.

2.3.11.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

(End of Scope of Work) Classified as Confidential image1.wmf