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STATEMENT OF WORK (SOW) Cost Per Reportable Testing Hemoglobin Analyzer Chalmers P. Wylie Ambulatory Care Center RFQ Number: 36C25021Q0681 Follow-on to Contract and Task Order Number: Not Applicable C... STATEMENT OF WORK (SOW) Cost Per Reportable Testing Hemoglobin Analyzer Chalmers P. Wylie Ambulatory Care Center RFQ Number: 36C25021Q0681 Follow-on to Contract and Task Order Number: Not Applicable Contract Title. Hemoglobin A1c and Abnormal Hemoglobin Testing Background. The Chalmers P. Wylie VA Outpatient Clinic Department of Pathology & Laboratory Service (P&LMS) requires a single, firm fixed price for a Cost per Patient Reportable Results (CPRR) contract, for 60-months for our patient population located in Central Ohio to perform Glycosylated Hemoglobin A1c (HbA1c) testing by High Performance Liquid Chromatography (HPLC) using direct measurements. The needed request would be a base +4 option years contract. At a minimum, the vendor shall be able to supply equipment/analyzers that can process from primary sample tubes without having to manually de-cap and recap the tubes, has an automatic clot detection/removal mechanism, supplies/reagents/consumables sequestered annually with the longest lot number expiration date possible to avoid continuous lot number changes; electronic inventory ordering system to which orders shall be shipped no later than 24 hours after receipt of requests and to arrive within 5-7 business days, technical telephone support 24/7/365, middleware that will provide standardizes process for result handling/review, and must meet the following requirements as provided in the Scope. The estimated annual volumes for HbA1c testing for Columbus VA is provided in Table 1 but does not guarantee volumes as listed; they are estimates only. The testing laboratory will fax or email their reportable test count (i.e. Number of patient samples run which is obtained from LIS and/or from the metering data within the analyzer software program) by the 10th of the following month to the awarded vendor. Table 1 ESTIMATED HPLC Glycohemoglobin A1C Testing Columbus VA OPC 2017 37551 2018 39823 2019 42555 2020 est. 37597 Lab 4 YR. Total 157526 Est. Lab Yearly Avg 39382 10% Est. Increase in Avg 43320 Est. Lab Monthly Avg 3610 DEFINITIONS Cost per Patient Reportable Result (CPRR) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition (This 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. Cost per Test (CPT) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (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 and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Metering: The calculation of the number of patient reportable results released per analyzer and the determination of inventory to be automatically replenished and shipped per analyzer. PERIOD OF PERFORMANCE Base Year: MONTH 1, 20XX through September 30, 2020 1st Option Period October 1, 20XX through September 30, 20XX 2nd Option Period October 1, 20XX through September 30, 20XX 3rd Option Period October 1, 20XX through September 30, 20XX 4th Option Period October 1, 20XX through September 30, 20XX 4. Scope. The vendor shall provide/install: New and the most current HPLC direct measurement of HbA1c analyzer which shall have the optional ability to link to a multifaceted automation line. Remanufactured or used models will not be accepted. A Cost per Patient Reportable Result (CPRR) model and a firm-fixed price task order for processing/ analyzing in-house testing on HbA1c assay to replace, without incurring testing delays or additional costs for 60 months. One primary analyzer system capable of performing the HbA1c where tests shall be vendor supported and they will be located at: Chalmers P Wylie VA OPC 420 N. James Rd Columbus, OH 43219 Attention: Laboratory The methodology shall be National Glycohemoglobin Standardization Program (NGSP) approved as well as Food and Drug Administration (FDA) approved for the analyzers, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, middleware and any/all other item required for the proper operation of the contractor s analyzer necessary to generate a list of patient reportable results on both the primary and back-up equipment/analyzers by an external printer. (This does not include those items approved for exclusion by the government such as printer paper, labels, etc.). Vendor shall supply external printer(s) that have the ability of printing a patient report, calibration data, and QC reports. Vendor shall state if chromatogram prints with each patient report or if the setting can be customized to only print patient reports that require review. Vendor shall supply printer/replacement printer(s) at no charge to the government. Equipment/analyzer must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. Analyzers that have accurate capability of monitoring reagent usage (metering) and provide inventory upon request, in real time. This will require the vendor to: Provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment /analyzer such that equipment/analyzer operations are not interrupted. Provide the items in 6.a to be of the highest quality, sensitivity, and specificity, and tested to assure precision and accuracy. The calibrators shall be traceable to International Federation of Clinical Chemistry (IFCC) reference standard. Clearly mark expiration date(s) on all reagents, standards, calibrators, and control containers. Post any delays in shipment and/or backorders as well as all technical advisory/recalls/alerts/notifications prior to or simultaneously post with field alerts. Unexpected changes in methodology/technology shall be at the expense of the vendor. The vendor shall reimburse the facility and/or facilities for ALL TOTAL costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility or facilities due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. In the event that any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor s equipment/analyzer, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery to the facility or facilities. If either circumstance has occurred, the vendor shall deliver to the facility or facilities, in the most expeditious manner possible, without additional cost to the facility or facilities, the necessary consumables in sufficient quaintly so testing is not delayed. The vendor shall state the manufactured warranted number of sample allowable per the column and filter(s) and shall describe the replacement process and associated costs when a column is found to be defective and does not meet the manufacturers stated warranty. Any routine and/or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, drainage systems, water systems, uninterruptible power supply (UPS), and surge protectors/suppressors. Also, to include any engineering controls necessary to maintain proper operating temperature(s). A UPS with line conditioner for each instrument provided. The vendor shall be responsible for battery replacement and/or replacing/repairing the UPS should it become dysfunctional. Set-up a flexible monthly supply delivery schedule. In the event that supplies/reagents/consumables are found to be defective and unsuitable for use with the vendors equipment/analyzer, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor is required to deliver replacement supplies/reagents/consumables with 24hours of receipt of a verbal order for emergency delivery at no additional cost to the Government. The vendor shall take into account that multiple runs of patient samples are performed daily and/or on each shift; therefore, the vendor shall work with each facility upon contract award and annually thereafter to adjust reagents, controls, calibrators, parts and/or supplies/consumables to match workload changes. Vendor shall pay all shipping costs/freight, or the analyzers and any crossover supplies needed at installation and during training of the laboratory staff. Vendor shall pay all routine shipping fees for supplies, consumables, and equipment parts required to perform patient testing. EQUIPMENT REQUIREMENTS Equipment specifications: (Bench top size) Dimensions: No larger than (H x W x D inches) 30 x 48x 40 Weight: no more than 150 lbs. Power requirements: AC 100-240; 50/60 Hz; 150-180 VA Operating temperature: 15-35 degrees C Operating humidity: 15-85% Analysis time: Less than 2 minutes per sample after the initial sample testing All equipment/analyzers must have 1) primary tube sampling capability,2) auto-mixing. 3) flexible tube sizes, 4) have cap piercing capabilities for employee safety, 5) No operator pre-treatment of samples prior to placing specimens on the analyzers, 6) continuous loading using an autoloader, and 7) shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. Equipment/analyzer shall accept EDTA whole blood samples and have the ability to analyze patient specimens up to 72 hours after collection. (The vendor shall state the sample stability for samples stored at room temperature and refrigerated.) Equipment/analyzer shall be able to perform testing on pre-diluted samples if needed. Equipment/analyzer shall have user defined reflex and repeat testing capabilities. Equipment/analyzer shall have STAT interrupt capability without compromising existing programmed testing. The methodology of the analyzers shall have the ability to accurately analyze HbA1c fraction without interference from other hemoglobin variants and have complete separation of the labile/stable hemoglobin A1C fraction. The methodology shall describe limitations and backup process for samples with low hemoglobin. The methodology of the analyzers shall have the ability to accurately analyze samples showing varying degrees of lipemia, hemolysis, and/or icterus without interfering with the stable HbA1c fraction. Ability to have the operator perform limited result reviews as possible. The equipment/analyzers must have a comprehensive Quality Control (QC) Program for all tests which includes at a minimum the following options: QC files may be edited or corrected for errors manually with/without password protection. On-board QC data storage and reporting capabilities. The ability to view/print daily and monthly QC results. The ability to view/print Levey Jennings graphs. The ability to access on-line documentation of out of range QC. The ability to program Westgard rules and/or other QC acceptance criteria built in. The ability to visually flag or audibly alarms when the QC is out of range. The ability to prevent/halt testing if the QC is out of range. The ability to exclude or include QC data points at the users discretion. The ability to for the QC management system shall have the storage capacity to hold at minimum 2 years of QC files and Levy-Jennings graphs. Compatible with Bio-Rad Unity QC Program to capture, store and electronically transfer QC data. Vendor shall list the reagents, calibrators, and controls that require any additional preparation prior to use such as warming/mixing/reconstitution and monitoring. The vendor shall provide method to determine integrity Column/Detector monitoring. Per CAP HEM.36005 Column/Detector Monitoring. The written procedure requires monitoring the performance of the column and detector on each day of use. Equipment/analyzer system shall have minimal reagent preparation and shall be able to load reagents without interrupting the operations of the analyzers or causing shutdowns/delays in testing. Equipment/analyzer shall have an inventory management system to alert operators of low reagents sufficient to accommodate both high and low volumes of use. Equipment/analyzer shall have On-board electronic troubleshooting guide capable of being activated on the screen and/or monitor with ease by the operator. Equipment/analyzer shall have automated and/or minimal maintenance capabilities provided by the operator for daily, weekly, monthly, periodic maintenance requirements, and on-board maintenance log. Equipment/analyzer shall have ease of calibration with extended calibration stability and reduced calibration frequency. Vendor shall specify the calibration frequency Per CAP HEM.35986 Calibration and Calibration Verification. Appropriate calibration or calibration verification is performed on each day of patient testing or more frequently if required by the manufacturer's instructions Equipment/analyzer shall be able to perform tests to specifications as defined by 1988 Clinical Laboratory Improvement Acts (CLIA) and Clinical Laboratory Standards Institute (CLSI) standards including satisfactory College of American Pathologist (CAP) peer group comparisons, coefficient of Variation (CV), and CAP calibration/verification comparison. Equipment/analyzer shall be able to store and retransmit records (24 hours of maximal instrument throughput and/or 5000 patient results for immediate recall) in case of interface downtime or power outage. The equipment/analyzer shall have an external and automatic backup function to store data form the hard drive (i.e. disc or flash drive). The vendor shall describe the back-up options. The Vendor shall state if there is an option to have multiple user levels for operation and if there is a limit to the number of users that can be given access to the analyzer. The equipment/analyzer shall have an automatic mechanism to be activated to inform the analyzer that a patient run is complete. Equipment/analyzer shall have the ability to monitor performance and alert the operator by way of audible alarm, pop-up screen, or flashing OPTIONAL: Equipment/analyzer can be linked to an instrumentation automation line. Computer Interfacing requirements (software and hardware) to be provided by the vendor as follows: The vendor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each item an instrument is added to an existing universal interface system. If a site already has a universal interface system, the vendor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g. licenses, ports, cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface system and one is needed to optimally interface the equipment/analyzer, the vendor is responsible for the acquisition of the universal interface box and everything required to connect with the VA computerized hospital information system with no charge to the Government. Equipment/analyzer LIS interface shall be bi-directional. If the host system software requires the use of non-proprietary universal interfacing system to provide bi-directional interfacing capabilities with Data Innovations System to achieve connection, the awarded vendor shall bear the cost of the interface including hardware and software. A bi-directional bar-coded computer interface with the ability to read standard barcode format such as Code 128 and Code 39. The Accuracy of the barcode reading must have less than 1% failure rate. The analyzer shall be able to support multiple barcode formats with a minimum of 10 characters in the specimen identifier. The vendor shall state if the barcoded tube orientation has to be manually designated or if the analyzer is capable of rotating the tube for sample identification. If there are any software upgrades to the instrument during its life, the vendor shall be responsible for ensuring the equipment/analyzer continues to interface appropriately with VA hospital information system. Equipment/analyzers Laboratory Information System (LIS) physical connection and translation (drivers) must be compatible with Data Innovations system. Any connections from the analyzers back to the vendor shall follow VA guidelines and has to be FIPS 140-2 and CRISP compliant. Windows 10 compatibility and hardware/software functionality for direct network connectivity. Any additional hardware and software needed to interface the equipment/analyzer and technical assistance with interfacing the equipment/analyzer. Software with user defined parameters to assist with auto-verification. Software and interface operations of the system shall be user friendly, with either point and click icons or touch screen for ease of operations. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA VistA and Cerner hospital information system. Interface Transfer of data is bidirectional and will occur in the following manner: VISTA (LIS) DATA INNOVATIONS INSTRUMENT The following data fields will be collected: Prime ID Specimen ID Patient ID Priority Action code Sample type Collect date Collect time Creation date Creation time Last name First name Middle name Sex Birthday Location Analyzer Station Test name Data is transferred from VISTA to a Data Innovations Secure Network Interface (SNI) device, which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the SNI which then sends the result back to VISTA in the appropriate format. All testing is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access and verify codes. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks in locked drawers behind locked doors) per regulations. Data will be available to providers using CPRS system. The above Protected Patient Information (PPI) will stay on the instrument s hard drive for about one month and then will be written over by new patient data. At the end of the contract the hard drive and any other data storing devices will be removed from the instrument and be taken to IRM for disposal. The vendor shall provide documentation of successful interfacing with other VA facilities (provide 2 VAHCS and/or VAMC references to include a contact person, facility address, email and telephone number.) INSTALLATION AND VAILDATION Vendor shall move equipment/analyzer, free of charge, to final testing location upon completion of validation process. Vendor shall provide, at no cost to the Government, at installation/set-up and when bringing new tests online, a technical support specialist who shall perform all validations studies including: Start-Up Reagents The vendor shall provide all reagents, calibrators, controls, linearity material, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish equipment/analyzers for operation, for performance of acceptance testing at no additional charge to the Government. This applies to all equipment/analyzers as well as additional or replacement equipment/analyzers placed under the terms and conditions of the contract. Installation/set-up Installation, startup assistance, and all validation studies of the equipment/analyzer shall be completed no later than 90 days after date of award. The performance period shall commence on the date of installation. Correlation Studies (evaluation/comparison data sufficient to satisfy CAP standards) Normal Range (reference range), accuracy, and recovery studies must be performed using samples representative of the patient population being tested. Reference range assessment must be performed for each lab Verification of reference intervals shall use one of the following protocols: A verification of the manufacturer s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be sued to verify the manufacturer range. Any apparent outliers shall be excluded from the reference range and new specimens obtained to provide statistically valid verification. If the suggested manufacturer s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference range must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be sued to establish a reference range. The reference interval should be determined using the nonparametric method. If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above mentioned protocols must be performed. Precision studies shall be performed using 10 normal and 10 abnormal control material. Intra-VISN facility variations should be kept to an absolute minimum (+/- 5% of the target value). Method comparison with current equipment/analyzers shall be at the expense of the vendor and shall be consistent with current CLSI guidelines and related documents, CAP standards, and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include whole blood, serum, plasma, urine, and all body fluids (as applicable). Analytical Measurement Range (AMR)(linearity) studies shall be performed on proposed equipment/analyzer for each anlayte to validate the reportable range Calibration verification studies per CAP HEM.36001 Limit of detection/AMR. A minimum of 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire AMR range shall be required and performed. Sensitivity studies may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. Specificity studies shall include a review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Carryover studies for reagents and samples shall be successfully completed by the vendor on all equipment/analyzers during installation/set-up. These studies shall be performed using either vendor developed programs or programs developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge to the Government. Per CAP HEM. 36010 Carry over detection. There is a written procedure for detection and evaluation of potential carryover. Vendor shall provide interpretation and all statistical analysis of raw data for each equipment/analyzer installed and provide a hard copy of data in an organized, clearly comprehensible format. Vendor shall provide on-site education and instrument training during installation and when there is an update to the equipment. Staff training is to include all shifts at designated times defined per facility. Training is to include basic operation, quality control, interpretation of results, reporting results, required user performed maintenance, and troubleshooting. Documentation of this training shall be completed for all trained staff before leaving site following installation at each facility. Assist with any methodology problems and questions. This service shall be available 24hours per day, 7 days a week, and 365 days a year including holidays. TRAINING The vendor shall provide initial Primary User Training for a minimum of one user per equipment/analyzer installed with on-site training available to remaining users on all tours with competency assessments performed and documented. Primary user training shall be arranged by the vendor and shall include all costs of off-site training. Vendor shall provide one (1) additional off-site training slot per instrument for each completed year of customer agreement included upon request. Vendor shall provide on-site training to the remaining users on all tours with competency assessments performed and documented. Vendor shall provide all necessary procedure manuals, troubleshooting manuals, and operator manuals (also available on computer disk format). Procedures shall be in the CLSI format. DELIVERIES/SERVICE AND MAINTENANCE Deliveries: Monday Friday, 8:00 a.m. to 10:00 a.m. excluding federal holidays. Delivery order: The participating facility may order products by telephone, facsimile, or other written communication, identifying the products, quantity, purchase price, address, for delivery, and any special instructions. a. 52.217-6Â Option for Increased Quantity b. 52.217-7Â Option for Increased Quantity-Separately Priced Line Item. Vendor shall provide assistance with support services, troubleshooting, and repair for all equipment/analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm) at no charge to the Government. If testing is unavailable due to analyzer downtime/malfunction, the vendor shall provide on-site service 24 hours/day; 7 days a week; 365 days/year including holidays. Certain circumstances may dictate the need for service to be conducted outside the routine business hours. All such arrangements shall be coordinated between the vendor and the VA laboratory personnel. Equipment/analyzer repair shall be no more than 24 hours. On-site service shall include, at no cost to the Government, all labor, travel, and all replacement parts necessary to make repairs. The vendor shall provide a 24/7 service hotline with technical support. The support service shall follow-up all downtime calls with one (1) hour of receiving the initial complaint. A down time (malfunction) incident report/service report shall be furnished to the laboratory upon the completion of each service/repair call to the COR. The report shall include: Date and time notified Date and time of arrival Serial number, type and model number of the equipment/analyzer Time spent for repair and proof of repair that includes documentation of a sample run of QC verifying acceptable performance. The vendor shall replace any consumable/part (i.e. supplies currently on hand at the facility) used by the Field Service Representative (FSR) at no cost to the Government. Each notification for an emergency repair service call shall be treated as a separate and new service call. The vendor shall provide timely visits for preventative maintenance performed by the vendor as required following manufacturer s operator s manual at no additional charge. Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintaining/troubleshooting user-defined assays as additional test/assays are brought in-house. The vendor shall supply engineering controls if necessary, for any heat, humidity, or noises issues that may results from the use of the proposed equipment/analyzer. The vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge (e.g. upgrades that correct or improve either the mechanical operation, or software of the system that would keep the equipment/analyzer performing optimally). The vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance tasks. Vendor shall indicate which tasks are user level and which are service representative level. The vendor shall state how new columns are verified for performance before use. Per CAP HEM.35992- Column Verification. New columns are verified for performance before use. Remote monitoring shall not be a substitute for on-site maintenance/repair service. However, the vendor may include remote monitored maintenance/troubleshooting software program that electronically transmits critical operational and administrative information from the equipment/analyzers to our internal systems via a secure Internet connection as a part of their offer. This secure, encrypted technology shall enable transfer of key logs, report generation, and remote service developments. It should also offer the potential to improve inventory management by enhances troubleshooting information made available to a technical support group, a portal to access instrument logs, files, maintenance information, software version, proactive instrument operations monitoring, predictive instrument maintenance, and QC data collection for peer review. The vendor shall provide a mechanism for the laboratory to meet local discharge requirements for reagents with hazardous constituents. The vendor shall supply information regarding any hazardous chemicals. BILLING Vendor shall bill monthly in arrears. Test counts for billing at each location shall begin after review and approval by the Columbus VA Hematology Lead, Core Labo...