SOW Urinalysis Reagents and Consumables wLeased Analyzer for Amendment.docx

STATEMENT OF WORK

Urinalysis Reagents and Consumables w/Leased Analyzer Cost per Patient Reportable (CPPR) Supply Requirement for Reynolds Army Health Clinic (RAHC), Fort Sill, Oklahoma

GENERAL REQUIREMENTS:

1.1SCOPE OF WORK: The contractor shall provide urinalysis reagents (including equipment, maintenance, and support at no extra cost to the government) in support of Reynolds Army Health Clinic (RAHC), Fort Sill, Oklahoma. The contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required to maintain the systems in optimal operating condition. The contractor shall perform to the standards of this Statement of Work (SOW).

1.2. The contractor shall perform to the standards of this Statement of Work (SOW). The contractor shall be responsible for installation, scientific studies (to include validations, correlations, linearity’s, etc. and maintenance. When awarded, the contractor shall have installation, and scientific studies completed no later than 30 days after delivery.

2.SPECIFIC TASKS

2.0. Description:

2.1. The contractor shall provide one (1) fully automated, discrete random access urine chemistry analyzer system capable of performing all the required assays to include the following additional components, one (1) fully automated urine particle analyzer, and one (1) digital imaging analyzer able to capture microscope quality images of urine particles when necessary for confirmation of any flags. The contractor shall provide training, supplies, reagents, unscheduled maintenance, preventive maintenance for the equipment and telephonic assistance. The analyzer system will be from a single contractor. The contractor shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. All equipment displays and supporting literature must be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS/DPALS QM guidelines and analyzer removal at the termination of the contract. Urinalysis testing shall be under a cost per test agreement or cost per patient reportable (CPPR).

2.2. For the purposes of this SOW the contractor and Urinalysis analyzer system includes at a minimum the following salient characteristics in support of the RAHC patient care operations at the RAHC main laboratory:

2.2.1. The analyzers shall be capable of interfacing with the laboratory's Laboratory Information System (LIS)Military Health System (MHS) Genesis. The contractor shall have an established driver compatible for interfacing with MHS Genesis. The interface between MHS Genesis and the analyzers shall be bi-directional.

2.2.2. The analyzers shall include a data management system for control of the operation of the analyzers, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer’s data management system.

2.2.3. The analyzer shall offer customizable and scalable start to finish automated urine chemistry testing with particle analysis, identification, and microscope quality digital imaging of particles to reduce percent of manual reviews and generate results on demand in less than one hour. The analyzer shall be floor standing or tabletop, and self- contained.

2.2.4. The analyzer shall offer dry-pad urine chemistry technology strips for urinalysis testing. Dry-pad urine chemistry technology is widely used across all medical centers, clinics, and point of care (POC) testing sites and to ensure standardization of results and better patient care the analyzer shall offer the same dry pad chemistry strip technology.

2.2.5. The urine particle analyzer system technology shall be able to automatically detect presence of crystals and differentiate without staff intervention between similarly sized RBC particles to ensure accuracy during proficiency testing as well as prevent falsely increased or decreased patient results.

2.2.6. The urine particle analyzer system technology shall provide a full spectrum of urine chemistry testing with minimum parameters for glucose, bilirubin, ketone, blood, pH, protein, urobilinogen, nitrite, leukocytes, and color; system parameters must capture specific gravity and clarity.

2.2.7. The analyzer shall provide automated urine analysis utilizing fluorescent flow cytometry providing accurate urine particle differentiation and counts and identifying and quantifying cells. The analyzer shall standardize the enumeration and reporting of 5 clinically important urinalysis parameters (RBCs WBCs, Bacteria, Epithelial Cells, and Casts), as well as flag the operator to the presence of potentially pathological parameters (Crystals, Yeast-like cells, Sperm, Mucus and Pathological Casts).

2.2.8. The analyzer shall offer microscope quality digital imaging for particle grouping by size to present to operator for classification and identification of pathological elements.

2.2.9. The analyzer shall offer minimal hands-on processing to streamline review of abnormal elements, reduce staff errors from proper particle identification and reduce the number of unclassified particles.

2.2.10. The analyzer shall not require any dilutions and special handling requirements for particle analysis.

2.2.11. Initial startup from the shutdown state shall not exceed 20-30 minutes. Minimal maintenance (<30 minutes) with walkaway capability to minimize staff hands-on requirement and free technologists for more critical tasks.

2.2.12. The analyzer system shall come equipped with an un-interrupted power supply capable of providing all necessary electrical power to all components of the urinalysis system, for a minimum of thirty (30) minutes.

2.2.13. The analyzer systems shall allow for growth and customization (i.e., increased numbers of patient testing or addition of assays). Urinalysis instruments shall have the option to provide a place for reagents and supporting products to provide the lab design flexibility for the future use and potential scalability for growing lab needs. The analyzer shall have a minimum throughput of up to 200 samples/hour.

2.2.14. The contractor shall provide ready to use reagents with good stability up to 14 days.

2.2.15. The analyzer systems and all reagents shall be FDA approved. Analyzers and associated parts and accessories shall be new. No used, refurbished or like-new equipment will be provided in support of the contract at any time.

2.2.16. The contractor shall provide the reagents/reagent packs, quality controls, calibrators/standards, user-replaceable maintenance items, and analyzer specific tools/supplies. Reagents used for troubleshooting analytical system shall be reimbursed (or replaced) by the contractor at no additional cost.

2.2.17. The contractor shall ensure reagents are shipped in a manner that will preserve the proper storage temperature during transportation and be delivered on time at the appropriate storage temperature.

2.2.18. The analyzer shall (must) have the ability to maintain reagents on-board at the proper storage temperature. All assays must be FDA approved.

2.2.19. Lab Layout: the offeror shall provide measurements or graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote.

· Any and all analyzers

· Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, etc)

· Automated Urinalysis System

· All equipment, software, middleware, and any network connections must have a government approved Authorized to Operate (ATO). The ATO must be completed and readily available on the Defense Health Agency (DHA) Consolidated System Tracking and Reporting (CSTAR) website.

2.2.20. The Urinalysis analyzer system will be delivered and located at:

Reynolds Army Health Clinic (RAHC) 4301 Wilson St.

Fort Sill, OK. 73503

2.2.21. Within 10 working days after contract award, contractor shall coordinate and conduct a post award site visit or conference call for the purpose of coordinating schedule for equipment installation.

2.2.22. Method Validation will be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP). Relevant guidelines listed in Appendix 1 (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

2.2.23. Method Validation will include but not be limited to, normal range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director. The Method Validation will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

2.2.24. The contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation.

2.2.25. All reagents, calibrators and linearity 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.

2.2.26. The government’s technical supervisor will obtain patient specimens for use in the Method Validation. In the event that specimen requirements for correlation studies cannot be met (e.g., insufficient number of patients to challenge the extremes of a curve), the contractor shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from contractor sources.

2.2.27. Both the contractor and contractor personnel at each location shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

2.2.28. The contractor shall provide two (2) paper and two (2) CD copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-government owned leased equipment that is serviced and maintained by the contractor.

2.2.29. The contractor shall provide material Safety Data Sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the contractor’s government representative. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain, as a minimum, identification of:

· The hazardous material

· The specific hazard

· The required practices for the safe use of the product

· First aid procedures

· What to do in the event of a spill or other mishap or accident.

2.2.30. The analyzer must not require any added expense for plumbing, drainage, or water systems. Self-contained, on-board water management eliminates special requirements for off-board plumbing.

2.2.31. The contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the government representative prior to shipment.

2.2.32. The contractor shall be responsible for the collection and transportation of equipment and all components upon termination of the contract.

2.2.33. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. These analyzer systems shall (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/analytic measurement range.

2.2.34. Minimum actual through-put shall be more than 100 samples per hour for urine chemistries and more than 50 samples per hour for particle identification.

2.2.35. All analyzer/data management system displays and supporting literature shall be in the English language.

2.2.36. The analyzer systems and all 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.

2.2.37. There shall (must) be a single point of specimen entry for the routine analysis of all required urinalysis tests. There shall (must) be an optional separate specimen point of entry for STAT specimens.

2.2.38. Initial startup from the shutdown state shall (must) not exceed 20 minutes.

2.3. Floor plan:

2.3.1. The analyzer shall be a tabletop instrument with the capability to customize and scale instruments if needed.

2.3.2. The bench top area where the analyzers will be located has a length of 142” wide and a 30” in depth with open storage space underneath.

2.4. Reagent requirements:

Possible Urinalysis Annual Volume

2.4.1. The workload is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or re-runs due troubleshooting or specimen dilutions.

2.4.2. The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care. In addition, workload may expand in subsequent option years due to fluctuations in patient volume, and with the inclusion of other locations within the Defense Health Network -West area. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

2.4.3. To account for expected fluctuations in workload, the contractor shall provide a “volume discount” based on exceeding the planned patient load each period of performance. As workload increases, the cost per reportable patient result or cost per kit should decrease. The workload shall be based on the total number of patient reportable results covered under the provisions of this SOW.

2.4.4. The analyzer shall (must) offer full spectrum of urine chemistry testing with minimum parameters for glucose, bilirubin, ketone, blood, pH, protein, urobilinogen, nitrite, leukocytes, and color; system parameters must capture specific gravity and clarity.

2.4.5. The analyzer shall offer Dry pad chemistry strip technology for urinalysis. Dry pad urinalysis chemistry strips are widely used across all medical centers, clinics, and point of care (POC) testing sites. To ensure standardization of results and better patient care we require the same dry pad chemistry strip technology already in use at the clinics and POC bedside testing be utilized.

2.4.6. All other reagents need not be maintained on an analyzer at the same time, but the analyzers provided shall (must) have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement (i.e., shall (must) allow the user to calibrate any assay, remove the assay reagents/reagent packs for a period of undetermined time, and then reload the reagents/reagent packs to run the assay without the need for recalibration in most instances, thereby allowing the user to meet test scheduling requirements specific to the location).

2.4.7. The contractor shall optimize the specific arrangement of the reagents/reagent packs for assays that are routinely maintained on the analyzer during the initial installation of the analyzer and when a new assay is added to the test menu. The contractor shall (must) ensure that all required reagents/reagents packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on each of the analyzers will be specified at the time of installation).

2.4.8. The contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of patient reportable tests for each assay.

2.4.9. The contractor shall provide quality control materials IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director. This includes third-party controls when requested/required by the laboratory.

2.4.10. The contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory Director and outlined in the Laboratory QA program), routine calibration, periodic calibration/calibration verification (i.e., each assay must be calibrated or have calibration verification performed at intervals not to exceed a 6-month period of time), specimen dilutions, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

2.4.11. The contractor shall estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks. An operator level maintenance tool/spare parts kit will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

2.4.12. Reagents shall (must) have a minimum shelf life of three (3) months upon receipt by the government, or, if this shelf-life requirement cannot be met, the contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal.

2.4.13. The contractor shall sequester the required quality control materials and test reagents and ensure that no more than one (1) lot change for QC material and three (3) lot changes for reagents occurs per contract year. Assays shall (must) be stable enough to maintain a single control run per 24 hours of testing. Calibration frequency for all assays shall not be less than once every twenty (20) days under routine operations. This calibration frequency does not include calibrations required following instrument repair or servicing (e.g., field service type maintenance or service, major changed in instrument components that affect readout, QC troubleshooting, etc.) or other instances as described in the Laboratory QA Program or approved by the Laboratory Director.

2.4.14. All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows: *

1. Be provided by the manufacturer of the equipment.

2. Be marked with the required storage temperature.

3. Be maintained at the proper storage temperature during transportation from the contractor’s storage facility to the government acceptance site and be delivered on time at the appropriate storage temperature.

2.4.15. The contractor shall provide the reagents/reagents packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services.

2.4.16. Deliveries - Deliveries of required items shall be per monthly periodic orders called in to the contractor by the government representative. Orders shall arrive within one week of requested date of delivery. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. In the instance a backorder exceeds 10 working days, the contractor shall provide testing services through local sub-contract at their cost.

Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested.

2.4.17. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All deliveries will be made Tuesday through Thursday, to exclude Federal Holidays.

2.5. Maintenance and Service:

2.5.1. MAINTENANCE. The contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required to maintain the systems in optimal operating condition.

The contractor shall maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the government.

2.5.2. The contractor shall 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 shall be performed by contractor service personnel in accordance with requirements as specified in the contractor’s instrument maintenance manual. Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services.

2.5.3. The contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with paragraph 2.4.3.1. of this SOW.

2.5.4. Repair: Upon notification of equipment failure, the contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the government notification to the contractors Customer Service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the contractor. Should both instruments become inoperable, the contractor’s technical specialist must be on-site within four (4) hours of initial notification. If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours. The contractor shall provide replacement parts as necessary for operator level maintenance.

2.5.5. The contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

2.5.6. The contractor shall replace all reagents, calibrators, controls and any other materials used by the government to trouble shoot the instrument failure prior to notification of the contractor.

2.5.7. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the government.

2.5.8. All correspondence, service reports, and invoicing shall be in English.

2.5.9. Preventive maintenance services shall be performed in accordance with the manufacturer’s standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

The contractor shall notify the government representative of the exact date and time for performance of a preventive maintenance service within ten (10) days prior to the scheduled preventive maintenance services.

2.5.10. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the contractor 's representative shall report to and obtain from the Equipment Management Branch, at the MTF a Visitors Badge. The badge must be returned to the Equipment Management Branch prior to departing the MTF.

2.5.11. Within one (1) working day after completion of a repair, the contractor’s representative shall furnish the government representative one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information:

· Nomenclature and serial number

· Date

· 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

2.5.12. The government and the contractor shall exchange hazard communication information before the commencement of any repair.

2.5.13. When required, the contractor shall comply with the Occupational Safety and Health Administration lockout and tag out procedures while performing maintenance on electrical equipment.

2.5.14. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Equipment Management Branch.

2.5.15. Preventive maintenance inspections and calibrations shall (must) be performed in accordance with contractor’s guidance as specified in the contractor’s instrument maintenance manual.

2.5.16. Service:

2.5.16.1 The contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

2.5.16.2. The contractor shall perform Preventive Maintenance Services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

2.5.16.3. The contractor shall provide a full unscheduled and PMS throughout the contract. PMS shall be at no additional cost to the government inclusive of all costs for the performance of scheduled periodic maintenance (as required by the contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

2.5.16.4. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding Federal Holidays.

2.5.16.5. The contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the contractor’s instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 48 hours after initial response by the contractor.

2.5.16.6. Upon analyzer failure, the contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement). The contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the government notification to the contractors Customer Service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the contractor.

2.5.16.7. The contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

2.5.16.8. The contractor shall replace all reagents, calibrators, controls and any other materials used by the government to trouble shoot the instrument failure prior to notification of the contractor.

2.5.16.9. The contractor’s qualified service technician shall ensure all repairs are completed and the analyzer is fully operational prior to departing the lab. In addition, the service technician or Customer Service “Hotline” will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 24 hours) after the service technician departs the lab.

2.5.16.10. Emergency Services and unscheduled services outside regular working hours, on weekends, and on Federal Holidays shall be listed as a separate line item. These services shall be conducted in the same manner as all other emergency services as described in 2.5.4. and 2.5.16.1. Estimated emergency visits per year are six (6).

2.5.16.11. Should both analyzers become inoperable, the technical repair specialist shall be on- site as described in 2.5.4. and 2.5.16.1

2.5.16.12. The contractor’s qualified service technician shall be on-site to provide unlimited emergency service as described in 2.5.4. and 2.5.16.1

2.5.16.13. The repair of at least one (1) analyzer must be completed within eight (8) hours of initial notification. If deemed necessary after consultation with the government representative, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the government representative shall arrange the pickup and delivery of critical specimens to a local College of American Pathologists (CAP) accredited clinical laboratory at the contractor’s expense.

2.5.16.14. During any period when both analyzers are inoperable, the contractor shall pay all costs associated with the provision of alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as both analyzers remain inoperable.

2.5.16.15. Hardcopy patient results shall provide all information as required in the Laboratory QA Plan and approved by the Laboratory Director. This information shall include, but not be limited to positive patient identification, laboratory results and the testing laboratory’s reference range for the test being performed.

2.5.16.16. If the equipment is out of service for longer than 48 hours (from the time-of-service technician’s arrival on site), the contractor shall notify the government representative in writing as to the reason(s) (i.e., non-availability of parts, etc.) for non-compliance.

2.5.16.17. The contractor shall provide all necessary user-replaceable maintenance items required to support the analyzer and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the government.

2.5.16.18. The government will make the equipment available to the contractor for servicing at such time and duration necessary to perform needed repairs.

2.6. Training:

2.6.1. The contractor shall provide initial on-site operator training to all technicians assigned to the government site (i.e., RAHC Dept. of Pathology Laboratory staff) prior to initiation of use of the analyzer for patient testing. In addition, the contractor shall provide training for two (2) primary operators, per analyzer at the contractor’s training site, prior to delivery and installation of the analyzer. The contractor will also provide one additional primary operator at the contractor’s training site if the laboratory is need of a new primary operator due to employee turnover or promotion.

The on-site operator training shall be provided by qualified contractor trained personnel using contractor-owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and troubleshooting.

2.6.2. The contractor shall provide two training slots per analyzer per contract year, at the contractor’s training site, at no additional cost (including transportation airfare, rental car, per diem, etc.) to the government. The contractor may charge the government only for training services exceeding the basic requirement for a given year.

2.6.3. The contractor shall provide on-site training for 8 technicians annually at no additional cost to the government or individual trainee.

The on-site operator training shall be provided by qualified contractor-trained personnel using contractor -owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and advanced troubleshooting.

2.6.4. All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

2.7. Information Management:

2.7.1. The analyzer system shall (must) be capable of interfacing with the military clinic computer system, i.e., the MHS-Genesis. The contractor shall (must) have an established driver compatible for interfacing the analyzer with the MHS-Genesis. The interface between MHS-Gensis and the analyzer shall (must) be bi-directional.

2.7.2. The analyzer system shall (must) include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system. The Data Management system shall have a comprehensive, fully integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred. The government utilizes the respective vendor’s quality control materials.

2.7.3. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

2.7.4. The QC software shall provide the capability to write user defined Westgard QC Rules. In addition it shall integrate with the result manager for auto verification of results, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall (must) include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

2.7.5. Data Management system shall (must) have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument useful life of the reagents/reagent packs, and management of patient results.

2.7.6. The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of the analyzer, monitors the lot number expiration date of on-board reagents and control materials. This shall be accomplished via communication connections between the automation, analyzers, and clinic Laboratory Information System (LIS).

2.7.7. The results management application shall manage patient data, sample and QC results by offering archiving, status, calculation of results and long-term results storage.

2.7.8. The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

2.7.9. Middleware capabilities shall include at a minimum the following features:

2.7.9.1. The capability to write user defined auto-verification/auto-result validation rules that can hold transmission of results for review by the user.

2.7.9.2. The capability to validate user defined auto-verification/result validation rules.

2.7.9.3. Support patient delta checks as part of the auto verification process.

2.8. Delivery of Equipment:

2.8.1. The analyzers shall (must) be delivered to the location as indicated below within 30 calendar days after contract award. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, shall (must) be completed by contractor personnel within a period of time to ensure that equipment is fully operational. During the initial implementation, a dedicated technical representative must be available on site throughout the entire implementation period. Substitutions must be coordinated with the government representative.

2.8.2. Primary location of complete systems:

2.8.2.1. The system shall be delivered and installed at:

Reynolds Army Health Clinic (RAHC) Department of Pathology 4301 Wilson St.

Fort Sill, OK. 73503

2.8.2.2. Exact installation location at the primary location shall be coordinated by the contractor with the point of contacts listed below:

Core Lab Supervisor and NCOIC Department of Pathology Reynolds Army Health Clinic (RAHC) Tel:

2.9. Safety Data Sheets (SDS):

The contractor shall provide material Safety Data Sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the government representative. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

3.0 Analyzer and Reagent Salient Characteristics:

3.1. The analyzer must have or be able to:

3.1.1 Provide customizable and scalable start to finish automated urine chemistry testing with particle analysis, identification, and microscope quality digital imaging of particles to reduce percent of manual reviews.

3.1.2. Urine particle counting analyzer should be able to automatically detect presence of crystals and differentiate without staff intervention between similarly sized RBC particles to ensure accuracy during proficiency testing as well as prevent falsely increased or decreased patient results.

3.1.3. Full spectrum of urine chemistry testing with minimum parameters for glucose, bilirubin, ketone, blood, pH, protein, urobilinogen, nitrite, leukocytes, and color; system parameters must capture specific gravity and clarity.

3.1.4. Dry pad chemistry strips for urinalysis are widely used across all medical centers, clinics, and POC testing. To ensure standardization of results and better patient care we require the same dry pad chemistry strip technology already in use at the clinics and POC bedside testing be utilized at the medical center.

3.1.5. Minimal hands-on processing to streamline review of abnormal elements, reduce staff errors from proper particle identification and reduce the number of unclassified particles.

3.1.6. Technology must provide fully automated urine particle analysis utilizing fluorescent flow cytometry technology providing accurate urine particle differentiation and counts and identifying and quantifying cells. The analyzer shall standardize the enumeration and reporting of 5 clinically important urinalysis parameters (RBCs WBCs, Bacteria, Epithelial Cells, and Casts), as well as flag the operator to the presence of potentially pathological parameters (Crystals, Yeast-like cells, Sperm, Mucus and Pathological Casts).

3.1.7. Should provide automatic color correction, thereby reducing false positives particularly for dark urines (bilirubin). This capability ensures the best patient care is provided.

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

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

3.1.10. No dilution required and no special handling requirements for particle analysis.

3.1.11. Must offer microscope quality digital imaging for particle grouping by size to present to operator for classification and identification of pathological elements.

3.1.12. Must have an approved Authorized to Operate (ATO) to access the government network for all hardware, software, and middleware.

3.1.13. Urinalysis instruments must have the option for an instrument cart or wagon with wheels to provide a place for reagents and supporting products to provide the lab design flexibility for the future and potential scalability for growing lab needs.

3.1.14. The contractor shall provide the reagents/reagent packs, quality controls, calibrators/standards, user-replaceable maintenance items, and analyzer specific tools/supplies.

3.1.15. Reagents used for troubleshooting analytical system shall be reimbursed (or replaced) by the contractor at no additional cost.

3.1.16. Reagents shall be shipped in a manner that will preserve the proper storage temperature during transportation and be delivered on time at the appropriate storage temperature.

3.1.17. Must provide a Bidirectional LIS interface.

3.1.18. Must not require any added expense for plumbing, drainage, or water systems. Self-contained, on-board water management eliminates special requirements for off-board plumbing.

3.1.19. Must have an approved Authorized to Operate (ATO) to access the government network for all hardware, software, and middleware.

3.1.20. All reagents and tests must be FDA approved and should exhibit at least 90% sensitivity and 90% specificity.

3.1.21. The contractor shall provide the reagents/reagent packs, calibrators/standards, user- replaceable maintenance items and analyzer specific tools/supplies.

3.1.22. Reagents used for troubleshooting analytical system shall be reimbursed (or replaced) by the contractor at no additional cost.

3.1.23. Reagents shall be shipped in a manner that will preserve the proper storage temperature during transportation and be delivered on time at the appropriate storage temperature.

3.1.24. Annual volumes are estimated quantities based on the current patient population and test requests. The government has the right to increase or decrease the quantity of each reagent/reagent packs based on changing patient population and test requests in accordance with FAR Clause 52.2 12-4 Contract Terms and Conditions — Commercial Items.

4.0. QUALITY CONTROL (QC) and QUALITY ASSURANCE (QA):

4.1. The contractor shall provide a Quality Control (QC) Plan that contains, a minimum, the items listed in 4.2.4 (below) to the Contracting Officer and government representative for acceptance not later than 10 days AFTER the start of the contract. The Contracting Officer will notify the contractor of acceptance or required modifications to the plan. The contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

4.2. The QC Plan shall include:

4.2.1. A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS). Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any government provided keys or lock combinations shall be included.

4.2.2. A description of the methods to be used for identifying and preventing equipment failure and/or defects.

4.2.3. A description of the records to be kept to document inspections and corrective or preventive actions taken. NOTE: The records of inspections shall be kept and made available to the government throughout the contract performance period and for the period after contract completion until final settlement of any claims, if any, under this contract.

4.2.4. Quality Assurance (QA) - The government representative will follow the methods of surveillance specified in this contract. Government personnel will record surveillance observations, as needed, and provide to the contractor. The receipt of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that the contractor has been made aware of the defective performance. Government surveillance may include observations/tasks not listed in the PRS. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the Contracting Officer as a result of surveillance will be according to the terms of this contract.

4.2.5. Equipment Troubleshooting: When the government performs troubleshooting with the contractor, the contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the government IAW Paragraphs 2.5.5. and 2.5.6.

4.2.6. Performance Evaluation Meetings.

4.2.6.1. The Contracting Officer may require the contractor to meet with the Contracting Officer and/or government representative, as deemed necessary.

4.2.6.2. The contractor may request a meeting with the Contracting Officer, when the contractor believes such a meeting is necessary. If required, written minutes of any such meetings shall be recorded in the contract and signed by the contractor and the Contracting Officer. If the contractor does not concur with any portion of the minutes, such non-concurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes.

5.0. HOURS OF OPERATION:

5.1. Normal Hours of Operation. Monday through Sunday between the hours of 0600 - 1800.

5.1.1. Holidays. Routine equipment servicing and reagent delivery will not be required on standard Federal Holidays. If an emergency arises, equipment servicing and reagent delivery will be provided in accordance with Section 2.5.16 of this SOW.

5.1.2. The contractor shall provide equipment maintenance service/direct customer service and support, 7 days a week as noted in 5.1., to include hotline telephone service, and direct connect remote instrument diagnostic capability to assist operators in correcting equipment operation problems.

6.0. CONSERVATION OF UTILITIES. During maintenance, the contractor shall make sure employees practice utilities conservation. The contractor shall be responsible for operating under conditions that prevent the waste of utilities to include:

6.1. Lights shall be used only in areas where work is actually being performed.

6.1.1. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

6.1.2. Water faucets or valves shall be turned off when not in use.

6.1.3. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility’s drain system, the contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

7.0. DEFINITIONS/ACRONYMS.

7.1. Definitions: Following is a list of basic definitions.

7.1.1. Contracting Officer: The ONLY person with the authority to enter into, administer, change, and/or terminate contracts and make related determinations and findings.

7.1.2. government representative: A government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract. NOTE: The government representative is not authorized to make any changes to the terms and conditions of the contract.

7.1.3. Quality Assessment and Improvement: Those actions taken by the government to check services to determine if they meet the requirements of the CLIA/DoD CLIP ’88 & ’03, CAP, Joint Commission, U.S. Army Medical Command, DHA, and U.S.