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Statement of Objectives (SOO) Urinalysis Analyzer and Reagents 1. Objective: 1.1 The Contractor shall provide Urine Chemistry reagent and a service agreement used in support of the Urinalysis testing ... Statement of Objectives (SOO) Urinalysis Analyzer and Reagents 1. Objective: 1.1 The Contractor shall provide Urine Chemistry reagent and a service agreement used in support of the Urinalysis testing mission at Reynolds Army Health Clinic (RAHC) and its surrounding clinics/healthcare network, located at or near Fort Sill, Oklahoma 73503. 1.1.1 - All costs integrated into this contract must be calculated on a Cost Per Reportable test. 1.1.2 - All supplies and equipment outlined in this Statement of Objectives must be supplied and serviced through a single Contractor to whom the contract is awarded, to include any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor. 2. Period of Performance: 2.1 Normal hours of coverage: Monday through Friday 7:00 AM to 11:30 PM, excluding federal holidays and additional Contractor Holidays. 2.2 Federal Holidays: The Federal Holidays observed by the Department of Defense include New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day and Christmas Day. Additional Contractor Holiday: Day after Thanksgiving; Christmas Eve; New Year's Eve. 2.3 Period of performance Base Option Year 1 Option Year 2 Option Year 3 Option Year 4 Instrument Purchase $34,033.33 N/A N/A N/A N/A CPRR- Reagent and Service Agreement $23,940 $23,940 $23,940 $23,940 $23,940 3. Contract Objectives: 3.1 RAHC wished to purchase one (1) fully automated, discrete, random access urinalysis analyzers capable of performing chemical (dipstick) analysis as well as automated microscopy with expected volumes as outlined below: Base Option Year 1 Option Year 2 Option Year 3 Option Year 4 Urinalysis Chemistry (Strip) Panel 9,000 9,000 9,000 9,000 9,000 Microscopic Analysis 9,000 9,000 9,000 9,000 9,000 3.2 Automated microscopy must use digital image analysis, provide automated pre-classification of the images, and present the digital images to the operator for review. 3.3 Must include all required peripherals, to include Uninterruptable Power Sources (UPSs), electrical line conditioners where required, instrument-specific computer terminals/CPUs, printers, other peripherals where required. 3.4 Each analyzer and associated peripheral (e.g., computers) item must be supplied with an Uninterruptable Power Source (UPS), electrical line conditioners where required, instrument specific computer terminals/CPUs and other required peripherals (e.g., air compressors) as required. The Contractor must provide or purchase and manage a service contract for each of these items for the duration of the contract. 3.5 For included printers, replacement ink cartridges must be supplied as needed by the contractor. 3.6 Must include a pedestal (floor stand) capable of supporting the analyzer system (as appropriate), computer terminal or other automated instrument/peripheral as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance). 3.7 Contractor must include full setup of the system, to include method verification which must include, at a minimum: 3.7.1 - Demonstration of linearity/verification of reportable range. 3.7.2 - Correlation to current methods 3.7.3 - Verification of precision and accuracy (as required). 3.7.4 - Carryover studies. 3.7.5 - Establishment of initial ranges using control materials, to include 3rd party controls as designated by the Medical Director. 3.8 All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the Method Validation Study will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care. 3.9 Systems, peripherals, and services must be integrated into a single cost per patient reportable result (CPRR) for the term of the contract. 3.10 For the Core Laboratory instrument, maintenance/service must be provided within 24 hours of instrument downtime, 7 days a week. Additional maintenance/service requirements are listed in section 7 of this SOO. 3.11 Design 3.11.1 The analyzer will need to fit on a counter space that is approximately 123 inches long X 23 inches wide. See room layout: 3.11.2 The analyzer must be self-contained with no additional hard plumbing requirements. 4. Equipment and Reagent Requirements: 4.1 The analyzer systems must have fully automated, discrete random access capabilities. There must be a procedure to allow priority analysis of STAT specimens. 4.2 The analyzer system must come equipped to perform continuous, random statistical analysis; capable of internal, real-time statistical Quality Control (QC). Each analyzer must include a comprehensive and fully integrated QC program that uses common statistical control rules (e.g., Westgard Rules). In addition, the QC program must be able to present data in a graphical format useful to detect shifts and/or trends in the QC system (e.g., Levy-Jennings charts). 4.3 The analyzer system must provide a chemistry strip panel that includes glucose, protein, blood/hemoglobin, nitrite, leukocyte esterase and specific gravity tests at a minimum Reagent List: Description QTY UNIT IQ LAMINA, 2 BOTTLES/BOX #800-3104 16 BX IQ CONTROLL/FOCUS SET #800-3104 16 SET IQ CALIBRATOR PACK #800-3103 4 PK IRIS SYSTEM CLEANER #800-3203 2 PK IRIS DILUENT PACK #800-3202 2 PK CHEMISTRY STRIPS VELOCITY#800-7212 200 BTL ICHEM WASH 2 BTL/CASE #800-7217 11 CS IRISPEC CA/CB/CC SET #800-7211 8 SET ICHEM VELOCITY CALCHECK #800-7703 4 KIT 4.4 The analyzer system must fully automate chemistry strip testing as well as microscopic analysis. 4.5 The analyzer system must present identified sediments to the operator as a digital image as well as provide a presumptive identification of each identified component during microscopic evaluation. 4.6 The analyzer system must provide a minimum test throughput of at least 50 urinalysis panels per hour, to include microscopy. 4.7 The analyzer system must have a computer interface that is compatible to the government system (CHCS) and will be able to recognize CHCS generated bar-code labels (code 39 or 128) on primary sample tubes. 4.8 Analyzer system routine manual maintenance will be minimized; no manual maintenance is preferred. 4.9 The analyzer system must have the on-board ability to maintain reagents at the proper storage temperatures; the analyzer system must not require routine unloading of reagents for storage. 4.10 The analyzer system must continually monitor volumes and expiration for all on-board reagents, providing a warning and testing lockout for reagents that are expired. 4.11 The analyzer system must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer's stated linearity/analytical measurement range. 4.12 All analyzer/data management system displays and supporting literature shall be in the English language. 4.13 Analyzer system initial startup from the shutdown state must not exceed 30 minutes. 4.14 The analyzer system must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes after loss of power. Further, electrical line conditioners must be provided to support each analyzer if determined necessary upon evaluation of the local facilities. 4.15 The analyzer system and all associated reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time. 4.16 All assays/reagents, calibrators and controls for the tests must be available directly through the Contractor. Reagents that are not manufactured by the Contractor must be provided through alternative means by the Contractor, to include any reagents, calibrators, controls or other required reagents. 4.17 All reagents, controls and calibrators (as required) must have a minimum unopened expiration date of at least 6 months beyond the date of receipt. 4.18 The analyzer system must provide an internal data management program that allows efficient control of quality control results, access to patient records and control release of results based on configurable clinical/technical rulesets. 4.19 Any and all data management systems must not require remote communication to sources outside of the facility to be functional. 4.20 The instrument/central data management system must be capable of interfacing with the military hospital computer system (the Composite Health Care System [CHCS]). The Contractor must have an established driver compatible for interfacing the analyzer and the central data management system with the CHCS. The interface between the CHCS and the analyzer must be bi-directional. 4.21 The software/hardware for each computer controlled system must have a large capacity to present/store graphics and results and present/store cumulative patient reports and quality control files with statistics. Information must be available to the user within a reasonable amount of time. 4.22 All components of the data management system must have a user friendly "Windows Based" interface. 5. Delivery and Installation Delivery and installation of all applicable equipment will be performed at the following location: Reynolds Army Health Clinic Department of Pathology, Core Laboratory 4301 Wilson Street Fort Sill, OK. 73503 The contractor will provide the COR and Property Book Office (PBO) a list with the make, model, serial number of each equipment item installed within the medical treatment facility (MTF). 6. Training 6.1 Contractor must provide the following for the testing locations at RAHC: 6.1.1 The Contractor must provide initial on-site operator training to all technicians assigned to the Government site normally assigned to perform the associated testing prior to implementation of the analyzer for patient testing. In addition, the Contractor must provide training for two (2) primary (key) operators, per major analyzer and automated system at the Contractor's training site at no additional cost to the Government (including transportation airfare, rental car, per diem, etc.) prior to implementation of the analyzer. 6.1.2 All on-site training must include basic analyzer operation, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use any data management/quality control software. 6.1.3 The Contractor must provide one primary (key) operator training slot per major analyzer and automated system per contract year, at the Contractor's training site, at no additional cost to the Government (including transportation airfare, rental car, per diem, etc.). 6.1.4 The Contractor may charge the Government only for training services that exceed the requirements for a given contract year. 6.2 We request training for two RAHC Biomedical Customer Service Technician to perform routine and corrective services per major analyzer and automated system at the Contractor's training site at no additional cost to the Government (including transportation airfare, rental car, per diem, etc.) prior to implementation of the analyzer. 6.2.1 All on-site training must include analyzer operation, troubleshooting procedures, performance and preventive maintenance procedures, and use any data management/quality control software. 6.2.2 The Contractor may charge the Government only for training services that exceed the requirements for a given contract year. 7. Service and Maintenance 7.1 Transportation. Transportation in support of any equipment and incidental support and maintenance services is the responsibility of the Contractor. The Government will not provide transportation. 7.2 Nametags. The Contractor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee. 7.3 The Contractor must meet the following service, and maintenance requirements for all testing locations at RAHC (except where specifically noted otherwise): 7.3.1 The Contractor shall provide direct customer service and support, 24 hours/ 7days a week, to include hotline telephone service (provided in English) and on-call emergency repair, to assist operators in correcting equipment problems. 7.3.2 The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. This includes emergency repairs as well as routine Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment and following the administrative procedures listed in section 7 of this SOO. 7.3.3 The Contractor must provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level must be performed by Contractor service personnel in accordance with requirements as specified in the Contractor's instrument maintenance manual. Completion of analyzer installation will establish time-zero for determining the time frame for performance of periodic services. 7.3.4 Any service technician provided by the Contractor must adhere to all required reporting procedures for RAHC prior to reporting to the laboratory for work. Current procedures will be available through the Contracting Officer's Representative (COR) or Alternate (ACOR) and are outlined in section 7 of this SOO. Any changes to reporting procedures will be communicated to the contractor by the COR or ACOR. 7.3.5 The service technician must be on-site to provide unlimited service within twenty-four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the contractor. 7.3.6 For equipment supporting other locations, the service technician must be on-site to provide unlimited service (service requiring repair) the next business day of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. 7.3.7 In all cases, the Contractor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot instrument failure. Replacement parts used, as necessary, claimed from local operator-level maintenance kits as well as any reagents that may have been used must be replaced at no cost by the Contractor. 7.3.8 The Contractor shall notify the COR or ACOR of the exact date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services. 7.3.9 Within one (1) working day after completion of a repair, the Contractor's representative shall furnish the COR one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch (EMB) and the Laboratory Representative for the Medical Treatment Facility (MTF). The report shall be in English and shall contain, as a minimum, the following information: Nomenclature and serial number Date of service Description of services performed (i.e., preventive Maintenance service, or unscheduled repair service) Location of services performed Duration of performance {hours) List of parts replaced or other actions taken to restore operability of the instrument Name of technician 7.3.10The Contractor must relocate/revalidate any instrument if requested by the Government at no additional cost. This includes any location within the RAHC healthcare network. Removal procedures for all government equipment are found in section 4 of this SOO. 7.4 The contractor's service representative shall report in person or telephonically notify the maintenance manager, building number 4301, telephone number 580-458-2126, prior to commencing services during normal duty operating hours Monday through Friday, 7:30AM to 5:00PM Reynolds Army Health Clinic Fort Sill, Oklahoma. During other than normal operating hours the contractor's representative shall report to the Administrative Office of the Day (AOD), building number 4301, telephone number 580-458-2800/2500/2801, located at the 1st Floor Information Desk. 7.4.1 The contractor shall check-in at Room GD112, Customer Service Desk, for ID badge upon arrival and check out when departing the service site. 7.4.2 Upon completion of services, the assisting Medical Maintenance technician will sign the service report to validate services performed. 7.4.3 If repairs are completed after 5:00PM, the contractor will sign in/out with the AOD and the Medical Maintenance technician on duty. 7.4.4 The government and contractor's service representative will communicate hazardous information before the commencement of any repair. 7.4.5 When required, the contractor's service representative will comply with the Office of Safety and Health Administration lockout/ tag out standards while performing maintenance on equipment. 7.4.6 Contractor's service representative will be factory trained and have a minimum of two years of experience working on the contracted equipment. 7.4.7 Contractor must furnish all software upgrades issued by the equipment manufacturer. 6.4h - Contractor shall have access to all necessary diagnostic software (if applicable). 7.4.8 Required forms and extracts from pertinent directives will be furnished to the contractor's service representative by the government. 7.4.9 The contractor shall keep the system in good operating condition, meeting all equipment and performance requirements published by the OEM. The contractor also assumes responsibility for system conformance with the latest published edition of NFPA-99, OSHA and CDRH. The contractor shall ensure that the system maintains their minimum uptime requirements 7.4.10 All equipment listed in Section 4 will be fully mission capable at a minimum of 95% of available time (uptime). Downtime is defined as the state when the system is not operable or available for routine clinical use. The start of the downtime period will be the time the contractor is notified by the COR or authorized designee. Scheduled preventive maintenance shall not be considered in downtime calculation. 7.4.11Minor system failures of ancillary components that do not affect system clinical use and availability will not be considered in downtime calculation. 7.5 The Contractor shall not remove any equipment from the Government work site without prior approval of the COR and PBO or his/her designated representative. (i.e. printer, UPS, monitor). The contractor shall notify the COR/PBO (in writing/e-mail) the intent to remove/exchange any equipment. The written notification will include the make, model, serial number of each equipment item that will be removed and the same information for the equipment being installed within the MTF.