Draft - SOW Chemistry CPRR - BPA 2023.docx

STATEMENT OF WORK

– Clinical Laboratory Chemistry Immunochemistry Instrumentation

1. BPA LANGUAGE

1.1. INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN (1) to establish a Blanket Purchase Agreement (BPA) for Automated Chemistry Immunochemistry Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/ Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The Government will award a CPRR BPA to a single Contractor for Automated Chemistry Immunochemistry Instrumentation. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment/herein and awarded in the final BPA. However, as requirements change, facilities within VISN 1 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract.

1.2. ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

1.3. PRICES AND TERMS: VISN 1 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY.

1.4. TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA for 5-years, and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor’s FSS contract. In addition, where a new FSS contract replaces Contractor’s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 1 intends to establish the base year of the agreement for the period of 4/1/2023 through 3/31/2028.

1.5. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity; CO: click here to insert identification numbers (BPA & FSS).

1.6. ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

2.1.2. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

2.1.3. If Contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

2.1.4. New equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A.

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

2.1.5.1. Quality Control material lot sequestering must be available. Sequestered lots must have an expiration date of >1 year.

2.1.6. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the regularly scheduled standing order/routine supplies delivery.

2.1.7. Any additional “value added” features, software, etc. should be included in the offer and will be evaluated by the technical evaluation panel.

2.2. DEFINITIONS:

2.2.1. 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. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce 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.

2.2.2. 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.

2.2.3. 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.

2.2.4. Primary Processing Automation Line – Pre-analytical processing equipment offered to each of the VA laboratories listed on Attachment A that will automate the pre-analytical specimen processing functions, as indicated in the general requirements section.

2.2.5. Specimen Management System - A component of the Processing Automation Line that directs and manages the operation and components of the pre-analytical processing/automation system.

2.2.6. Contractor Middleware Management System - For the purposes of this solicitation, this is a separate component or module that electronically connects the testing instrumentation to manage data, results, and workflow of 2 or more pieces of instrumentation. (Not to be confused with middleware for interfacing equipment with the hospital/laboratory information system.)

2.2.7. Throughput – The speed that the equipment processes and/or operates reported in units per hour.

2.3. Test Menu – Refer to Attachment A Workload Est Tab for desired test menu and estimated annual volumes by laboratory.

2.4. GENERAL REQUIREMENTS

2.4.1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

2.4.2. Back-up Analyzer DOES apply ; equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e., reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Additional primary analyzers required for the performance of daily workload are not considered back-ups for the purposes of consumables, reagents, etc.

2.4.3. Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and be available on the Contractor’s FSS Contract at the time of proposal submission and have the following:

2.4.3.1. Primary Processing Automation Line Instrumentation. does apply; Processing Automation Line Instrumentation for Clinical Laboratory Chemistry/Immunochemistry Instrumentation may be comprised of the following modules: specimen management system, centrifuge, decapper, recapper/sealer, aliquoter, and refrigerated storage which are connected with an automated track or line according to the requirements of each respective laboratory. The Processing Automation Line Instrumentation shall have the following:

Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

Specimen management system to manage and track sample progress and position.

Specimen archival system that maps specimens to racks or refrigerated storage for easy retrieval once moved from the automation line. (Specimen Management System).

The ability, based on test requests, to sort specimens. (Line/Track System/ Specimen Management System) The ability to connect by a line or track system all primary and back-up testing analyzers offered in accordance with Attachment A (Line/Track System).

The ability to send processed specimens by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. (Line/ Track System / Specimen Management System) The ability to prioritize STAT specimens. (Specimen Management System) Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen. (Specimen Management System) The ability to detect processing errors and provide error notification. (Specimen Management System) The ability to replace and/or reseal a variety of types and sizes of blood collection tubes. (Recapper/Resealer) The ability to maintain and store specimens from 2-8 degrees centigrade.

Barcoding stations located at key points along the line or track system must have the following capabilities:

A barcode reading accuracy rate of 99% or greater for any component that requires barcode reading.

Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

The contractor is responsible for the removal of all current automation line equipment if a new primary processing automation line is installed as part of the award.

Equipment must accept, at a minimum, 10 characters in specimen identifier that is

2.4.3.2. Testing Instrumentation: The testing instrumentation must be approved by the Food and Drug Administration (FDA) and be available on the on Contractor’s FSS Contract at the time of proposal submission and shall have the following:

2.4.3.2.1. The capability of performing analysis on the tests listed in Attachment A Workload Est Tab.

2.4.3.2.1.1. Must be able to offer all tests on the current test menu while maintaining or reducing the number of workstations.

2.4.3.2.1.1.1. If during the course of the CPRR a test becomes unavailable another method for testing must be provided (i.e., an additional instrument).

2.4.3.2.2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A.

2.4.3.2.3. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system-

2.4.3.2.3.1. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

2.4.3.2.3.2. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and numeric concurrently that may be enabled concurrently.

2.4.3.2.3.3. A barcode reading accuracy rate of 99% or greater.

2.4.3.2.3.3.1. If a barcode is not read on a patient sample, the instrument must alert the user that a sample was not read.

2.4.3.2.4. An instrument management system (internal to testing instrumentation) that provides/maintains the following:

2.4.3.2.4.1. On-board QC data management system with minimum storage capacity of 35 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

2.4.3.2.4.2. Ability to monitor instrument performance.

2.4.3.2.4.3. Continuous monitoring of vital instrument functions with immediate operator notification of failure(s). A record(s) of the vital instrument function failure(s) must be maintained and stored electronically on-board the equipment.

2.4.3.2.4.4. Capability to detect and alert operator of out-of-range quality control results via flagged results on QC printout and visual alerts on display monitor.

2.4.3.2.4.5. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

2.4.3.2.4.6. Capability to capture, store and print the following information:

2.4.3.2.4.6.1. Instrument maintenance information.

2.4.3.2.4.6.2. Patient demographic information.

2.4.3.2.4.6.3. Specimen results.

2.4.3.2.5. On board reagent inventory management system must have:

2.4.3.2.5.1. A system that provides reagent data to include but not limited to lot number, expiration date, and the number of remaining tests available for use on the analyzer (per analyte).

2.4.3.2.5.2. Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology.

2.4.3.2.5.3. A barcode reading accuracy rate of 99% or greater.

2.4.3.2.6. Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen. The introduction of a STAT specimen must not compromise existing programmed testing.

2.4.3.2.7. On board reagent stability sufficient to accommodate both high and low volume use.

2.4.3.2.8. The ability to detect and alert operator of low liquid levels and the potential of depletion.

2.4.3.2.9. The ability to unload/remove empty reagent containers from the equipment during operation without interrupting testing in progress.

2.4.3.2.10. The ability to calibrate and support more than one (1) reagent lot of the same reagent on the equipment at the same time.

2.4.3.2.11. The capability to calibrate assays during test run without aborting the run.

2.4.3.2.12. The capabilities to store, print, and retrieve calibration data.

2.4.3.2.13. The ability to continuously load patient specimens.

2.4.3.2.14. The ability to detect short samples.

2.4.3.2.15. Clot detection with alert notification.

2.4.3.2.16. Primary tube sampling from evacuated collection tubes of various sizes and from various manufacturers.

2.4.3.2.17. Capable of handling all routine sample collection tubes plus other various sized sample containers, e.g., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts.

2.4.3.2.18. The capability to auto dilute a test when defined limits are exceeded. (Contractor shall indicate on Attachment A Misc. Info each analyte that can be set to auto dilute on each instrument model offered.)

2.4.3.2.19. The capability to program a test to perform a repeat analysis. The repeat test result must be able to cross the interface and overlay the initial result.

2.4.3.2.20. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

2.4.3.2.21. For those sites requiring back up analyzers, it would be desirable for the backup analyzer to be a mirror image or have the same reagent requirement as the primary analyzer.

2.4.3.2.22. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

2.4.3.2.23. IDMS traceable Creatinine reagent.

2.4.3.2.24. Minimal requirements for sample pre-treatment.

2.4.3.2.25. Minimal carryover.

2.4.3.2.26. Long calibration stability.

2.4.3.2.27. The capability of incorporating other manufacturer’s reagents.

2.4.3.3. Contractor Middleware Management System must have

Sufficient memory to store patient information and 50,000 test records with downloading capability to an 140-2 FIPS compliant external medium for long term storage of patient records and other information.

Patient status display for technologist review.

Supports workflow management that supports all integrated (linked) testing instrumentation.

Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

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

Technology to automatically direct additional specimen testing based on customer configurable testing criteria (reflex technology).

Auto verification of Laboratory Results -Contractor shall collaborate with each lab to develop and write protocols to establish customer configurable rules to enhance workflow management and productivity. Auto verification system/protocols must be compatible with VA VISTA.

Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

2.4.4. Hardware Features- The instrumentation shall have the following:

2.4.4.1.1. All monitors/screens will clearly display information in all light conditions.

2.4.4.1.2. A printer(s) that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID). If printer(s) will not be provided the instruments must have the capability of attaching a local printer and a list of compatible printers will be provided.

2.4.4.1.3. An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc.,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

2.4.5. Specific Equipment Requirements-

Patient testing is disabled if QC failure occurs.

The technology to electronically transmit quality control and instrument function checks and maintenance information to the Contractor Middleware Management System.

The technology to electronically transmit quality control to 3rd party quality control vendors.

The technology to print results in real time or on demand, as well as an option to print exception reports held in the middleware for auto verification purposes.

Equipment relocation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for two (2) relocations within each site.

Quality Control (QC) material is required to be included in this BPA. The CPRR price shall include quality control products, including 3rd party quality control materials if necessary.

Alternative QC material must be available for troubleshooting purposes.

For general chemistry tests, when more than one lot of a given reagent has a valid calibration on the analyzer and quality control material is programmed to run as a control (in the control mode):

Quality control material will automatically be run on all lots of those reagents when the respective test is requested.

Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor.

Operator may select to run a test on only a specified lot of reagents even though more than one lot has a valid calibration.

Must have an automated benchtop decapper for sites that specified this functionality on the Chemistry IPT attachment.

Ability to run 3rd party testing such as Ethyl glucuronide (ETG)and Fentanyl (open channels required).

Any materials needed for 3rd party reagents will be provided (i.e., labels) Windows XP is not acceptable. Computer operating system must be Windows 10 or above.

HIV 1/2 Antibody/antigen testing must be 4th generation or higher at the time of award.

Troponin- availably of both traditional Troponin and High Sensitivity Troponin will be viewed favorably BNP- availably of both traditional BNP and ProBNP will be viewed favorably Please list any assays that rely on biotin- streptavidin binding or biotinylated antibody as part of the assay architecture. Describe how this affects patient results.

2.4.6. Method Performance/Validation Requirements-

Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations and will follow the NCL New Instrument/New Test Policy attached. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids, as applicable. These validation requirements are applicable to all new testing analyzers.

Correlation studies for each analyte. A minimum of samples spanning the reportable range, shall be run comparing the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

Linearity Studies – instrument software must provide linearity reports that include all necessary parameters (i.e., mean, bias, slope, y-intercept, correlation coefficient) or data crunching of 6-month linearity studies shall be included at no additional cost. Calibration verification included on linearity studies where applicable.

Precision study using normal and/or abnormal control material. This shall include, at a minimum, within run precision study of 20 controls. In addition, between run/day-to-day precision study will be run for a minimum of 20 times over a minimum of five days using a sample with a value that approximates the mean of the reference interval.

Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine specificity, sensitivity, false positive rate and false negative rate are applied.

Interference Studies. The vendor will provide a review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

2.4.7. Reference Range- A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

2.4.7.1. 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 used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

2.4.7.2. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

2.4.7.3. 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 items must be performed.

2.4.8. Additional Features:

2.4.8.1. All additional features

2.4.9. Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. These reports will be in an Excel spreadsheet; multiple tabs may be used, to include a VISN summary tab. Attachment A Workload Est Tab may be used as a template to provide these quarterly reports.

2.4.10. Support Features-

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

2.4.10.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, 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 instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this BPA. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and provide a hard copy of data in an organized, clearly comprehensible format.

2.4.10.3. Training. The Contractor shall include an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

2.4.10.4. In addition to the training above the following shall be provided:

2.4.10.4.1. Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable.

2.4.10.4.2. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization.

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

2.4.10.6. Service Requirements

Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date. Maintenance will be coordinated and performed at a mutually acceptable time with the laboratory supervisor and clinically engineering staff.

Daily, weekly and monthly maintenance will be performed by the end users. All other scheduled maintenance (i.e., quarterly, tri-annually, annually) will be performed by the vendor.

A technical assistance center shall be available by telephone 24 hours per day, 7 days per week, 365 days a year, with a maximum call back response time of s.

Follow-up calls from a Field Service Engineer, when necessary, shall have a maximum call back response time of 1 hour.

Equipment repair service shall be provided at a mutually acceptable time coordinated with the laboratory staff. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

Equipment repair response time shall be no more than hours.

A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call within 5 days. The report shall include, as a minimum, the following:

date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

2.4.10.7. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These upgrades will include any current/future VA mandated hardware or software requirements. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability.

2.4.10.8. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate each analyzer independently as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumables, preventative maintenance and repair including, all parts, etc.), keyboard, mouse, printers and universal interface equipment, etc. When multiple analyzers are included in the offer, each must have its own ancillary support equipment. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

2.4.10.9. Interface Requirements-

The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

If a site already has a universal interface system, the Contractor is responsible for any additional hardware and 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 there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

The Specimen Management system must be computer interface compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

A VHA Form 6550 must be completed by the contractor, VA approved and submitted with the offer.

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

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

2.4.10.11.1. The determination and description shall address the following:

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

2.4.10.11.1.2. Waste ignitability (Reference 40 CFR §261.21)

2.4.10.11.1.3. Waste corrosivity (Reference 40 CFR §261.22)

2.4.10.11.1.4. Waste reactivity (Reference 40 CFR §261.23)

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

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

2.4.10.11.1.7. Solid Waste (Reference 40 CFR §261.2)

2.4.10.11.1.8. Exclusions (Reference 40 CFR §261.4)

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

2.4.10.11.3. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosal, and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

· pH

· Flash point (to higher than 200°F)

· BOD; biochemical oxygen demand

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

2.4.10.12. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120 day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.4.10.12.1. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 120 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.4.10.12.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 120 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

2.4.10.12.3. At the end of 120 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

2.4.11. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any proposal at an effectiveness level of 90% or more. [reference: Master FSS]

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

2.4.11.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

2.4.11.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

2.4.11.4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. [reference: Master FSS]

2.4.11.5. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.4.11.6. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. [reference: Master FSS] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this BPA, i.e., water system UPS, etc.

2.4.12. Security Requirements- The Contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing information.

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

2.4.14. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

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

2.4.16. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.6, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA.

2.4.17. All electronic storage media used on non-VA leased or non-VA owned IT…