36C24726Q0774 Source Sought.1.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* Columbia Immunoassay Chemistry Reagents New Base Plus 4 Year Option

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 29209-1639

SOLICITATION NUMBER* 36C24726Q0774

RESPONSE DATE/TIME/ZONE 08-20-2026 1100 EASTERN TIME, NEW YORK,

USA

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6630

NAICS CODE* 334516

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs

W.J.B. Dorn VA Medical Center

6439 Garners Ferry Road

Columbia SC 29209-1639

POINT OF CONTACT*

Howard J. Montgomery howard.montgomery2@va.gov

PLACE OF PERFORMANCE

ADDRESS W.J.B. Dorn VA Medical Center

6439 Garners Ferry Road

Columbia SC 29209-1639

POSTAL CODE

COUNTRY

This is not a solicitation announcement. This is a sources sought synopsis for market research purposes ONLY. The purpose of this synopsis is to gain knowledge of potential qualified vendors that can provide the Immunoassay Chemistry Reagents Service relative to NAICS 334516 (size standard of 1,000 employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After reviewing the responses to this source sought synopsis, a solicitation announcement may be published in the

FedBizOpps or GSA eBuy websites. Responses to this source sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this source sought announcement. The Department of Veterans Affairs, Network 07 Contract Office, is seeking sources to provide:

The Columbia VA Healthcare System (CVAHCS) will award a Firm Fixed Price (FFP) type contract to a single contractor for Fully Automated Chemistry and Immunochemistry

Instrumentation, automated track, and refrigerated blood storage; all associated reagents and ancillary services.

If you are interested and can provide the required supplies, please provide the requested information as indicated below.

All RFI’s must provide the following information in this format:

1. Company Name:

Address:

Phone Number:

2. Point of Contact:

Email:

Phone Number:

3. Company Unique Entity ID (Found at SAM.GOV)

4. Company Business Size (Large, SDVOSB, Small etc.)

All RFI’s must provide the answers to the following questions:

(1) Is your company considered small under the NAICS code identified under this RFI?

(7) Please provide general pricing for your /solutions for market research purposes.

(8) Please submit your capabilities regarding the Performance Work Statement to establish capabilities for planning purposes.

Responses to this notice shall be submitted via email to: howard.montgomery2@va.gov

Telephone responses will not be accepted. Responses must be received no later than

08/20/2026 at 11:00 AM EST. If a solicitation is issued it shall be announced later, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.

STATEMENT OF WORK

11. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

11.1. SCOPE OF PROCUREMENT:

11.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the Performance Work Statement. The instrument shall have random access capability (if discrete testing is required) and can simultaneously perform the complete profile as described below meeting 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).

11.1.2. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

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

11.1.4. Equipment shall be acquired for the clinical laboratory located at the Dorn VAMC, 6439

Garners Ferry Rd. Columbia, SC 29209.

11.1.5. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials, to include replacement parts, 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.

11.1.6. The Contractor will provide a detailed list of all parts and supplies that are to be purchased by the facility and are not included in the CPRR contract.

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

11.2. DEFINITIONS:

11.2.1. 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. This 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.

11.2.2. Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical

11.2.3. 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, linearity material, calibration verification material, 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.

11.2.4. 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 receive, 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.

11.2.5. Specimen Processing Automation Line – Pre-analytical processing and archival processing equipment offered to each of the VA laboratories listed on attachment A that will automate these specimen processing functions, as indicated in the general requirements section.

11.2.6. 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.

11.2.7. Contractor Middleware Management System - A server installed with software that interfaces the testing instrumentation to the Laboratory Information system and is able to receive, process and send data following CLSI guidelines.

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

11.2.9. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes by laboratory.

11.2.9.1. Special testing requirements:

11.2.9.1.1. HIV Methodology shall be 4th generation or higher.

11.2.9.1.2. Rapid testing for cardiac marker Troponin I or Troponin T (15 minutes or less)

11.2.9.1.3. Biotin-free or biotin-resistant reagents

11.2.9.1.4. Chemistry Automation customizable

11.2.10. GENERAL REQUIREMENTS:

11.2.10.1. 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.

11.2.10.2. (Applies only if selected) Back-up Analyzer; 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. Specific tests that require back-up performance are listed in Attachment A. Additional primary analyzers required for the performance of daily workload are not considered back-ups for the purposes of consumables, reagents, etc.

11.2.10.3. Contractor will perform a mini-validation when instrumentation is installed in the final workspace.

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

11.2.10.5. Primary Processing Automation Line Instrumentation. Offering for an Integrated

Clinical Laboratory Chemistry/ImmunochemistryInstrumentation and Robotics System

(Automated track or line) in accordance with the requirements of each respective laboratory, shall have the following:

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

11.2.10.5.2. Includes a specimen management system to manage and track sample progress and position.

11.2.10.5.3. Specimen archival through mapping of specimens to racks; for easy retrieval once moved off-line. (Specimen Management System).

11.2.10.5.4. The ability, based on test requests, to sort and route specimens. (Line/track system/ Specimen Management System)

11.2.10.5.5. The ability to send the primary tube or processed aliquots 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)

11.2.10.5.6. Minimal operator intervention to introduce STAT specimens or to change a routine specimen

11.2.10.5.7. The ability to detect processing errors and provide error notification. (Specimen

Management System)

11.2.10.5.8. The ability to separate the serum/plasma from the blood cells through the process of centrifugation. (Centrifuge)

11.2.10.5.9. Ability to detect short samples and clots (Aliquoter)

11.2.10.5.10. The ability to remove caps from blood collection tubes. (Decapper)

11.2.10.5.11. The ability to recap and/or reseal - tubes. (Recapper)

11.2.10.5.12. The ability to remove an aliquot of serum/plasma using disposable pipette tips to prevent contamination and move into another specimen tube or cup for analysis. (Aliquoter)

11.2.10.5.13. The ability to print bar code labels and label daughter (aliquot) tubes to maintain positive specimen identification.

11.2.10.5.14. The ability to connect all primary and back-up testing analyzers offered in accordance with Attachment A

11.2.10.5.15. Ensure immediate availability of primary tube after processing.

11.2.10.5.16. The ability to auto-archive, store and retrieve specimens from 2-8 degrees centigrade.

11.2.10.5.17. (Refrigerated archival storage). Capacity to be determined by Attachment A

11.2.10.5.17.1. Barcode reader stations must have the following capabilities:

11.2.10.5.17.2. The accuracy of the barcode reading must have less than a 1.0 % failure rate.

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

11.2.10.5.17.4. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently.

11.2.10.6. Testing Instrumentation The testing instrumentation must be an integrated platform with flexible, modular components that can be upgraded with the most recent upgrades and technology and or reconfigured on site and is approved by the Food and Drug

Administration (FDA) and on Contractors’ FSS Contract at the time of proposal submission and shall have the following:

11.2.10.6.1. The capability of performing analysis on 100% of the tests listed in Attachment

A.

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

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

11.2.10.6.3.1. Ability to monitor instrument performance.

11.2.10.6.3.2. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records.

11.2.10.6.3.3. 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.

11.2.10.6.3.4. Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum of 48 hours in case of interface outage.

11.2.10.6.3.5. Capability to record, store and print the following information:

11.2.10.6.3.5.1. Required quality control and instrument maintenance information.

11.2.10.6.3.5.2. Patient demographic information and specimen results.

11.2.10.6.3.6. On board reagent inventory system.

11.2.10.6.4. 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.

11.2.10.6.4.1. The accuracy of the barcode reading must have less than a 1.0 % failure rate.

11.2.10.6.4.2. Equipment must be able to support multiple barcode formats (Code 39, Code

128) that may be enabled concurrently.

11.2.10.6.4.3. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and/or numeric depending on site that may be enabled concurrently.

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

11.2.10.8. Ability to prioritize STAT testing without compromising existing programmed testing.

11.2.10.9. Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a

11.2.10.10. STAT specimen, as well as introduce STAT specimens during a test run without aborting a run.

11.2.10.11. On board reagent stability sufficient to accommodate both high and low volume use. See Attachment A.

11.2.10.12. The ability to detect and alert operators of low liquid levels and the potential of depletion.

11.2.10.13. The ability to load and unload all reagents from the equipment during operation

(on the fly) without interrupting testing in progress.

11.2.10.14. The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations.

11.2.10.15. The ability to calibrate more than one lot of a reagent at a time.

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

11.2.10.17. The capability to store, print, and retrieve calibration data.

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

11.2.10.18.1.1. Operatory shall be notified if a new lot number is about to be run to ensure that quality control material is performed.

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

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

11.2.10.19. The ability to continuously load patient specimens.

11.2.10.20. The ability to detect short samples.

11.2.10.21. Clot detection with alert notification.

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

11.2.10.23. The instrumentation should be capable of handling all routine sample collection tubes e.g.: 13x75, 13x100, 16x100. Plus, other various sized sample containers i.e., sample cups

(0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts.

11.2.10.24. The capability to auto dilute a test when defined limits are exceeded. (Contractor shall list all analytes that can be set to auto dilute on each instrument model offered.)

11.2.10.25. The capability to program a test as a repeat with interfacing of results to overlay initial result.

11.2.10.26. 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.

11.2.10.27. 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.

11.2.10.27.1. Ability to store and retransmit records (48 hours of maximal instrument throughput) in case of interface outage.

11.2.10.28. IDMS traceable Creatinine reagent

11.2.10.29. Stable calibrations

11.2.10.30. User defined/Open Channel test capability. If the contractor cannot provide desired assays, the contractor will provide application development support for open channel test implementation.

11.2.11. Contractor Middleware Management System

11.2.11.1. The Contractor shall provide instrumentation that interfaces directly with Data

Innovations’ Instrument Manager Middleware and support auto-validation. The most recent version of the middleware will be updated at no cost to the government.

11.2.11.2. The Middleware shall be able to communicate via HL7 messages version 1.5 or later (most up to day HL7 version will be required to be able to communicate.

11.2.11.3. Middleware for clinical chemistry systems should be open for bidirectional interfacing of front automation, reference laboratories, laboratory/clinical information systems, third party middleware applications, and laboratory instrumentation, current and future generations, for all other vendors and/or laboratory sections at no additional cost.

11.2.11.4. The Contractor shall provide the server(s) and Data Innovations’ Instrument

Manager Middleware software, and provide technical support for both the hardware and software for the duration of the contract.

11.2.11.5. All driver development shall be provided by the respective vender, free-of-charge.

11.2.11.6. The middleware should have the ability to interface with regulatory agency applications.

11.2.11.7. The Contractor shall assist in the provision of the appropriate software drivers and interfaces for effective use of automated regulatory agency reporting features.

11.2.11.8. The Contractor shall assist in the establishment, testing, deployment, auto validation and troubleshooting of the full capacity of the Middleware.

11.2.11.9. The Middleware shall contain modules that facilitate the analysis of laboratory pre-analytic, analytic, and post-analytic processes and the generation of summary reports for quality improvement and monitoring efforts.

11.2.11.10. Summary reports shall be interactive, customizable, and accessible on-demand.

11.2.11.11. Reports shall have, at a minimum, the flexibility to display information organized by department,

11.2.11.12. workflow unit, desired time frame, production phase and priority. Software shall have the capability to drill down within the summary reports, identify problematic data and generate corrective action plans.

11.2.11.13. Canned summary reports shall include, at a minimum: Turn around time, specimen and test volumes, instrument quality control, specimen quality indicators, % auto-verification, % (and number) repeat tests.

11.2.11.14. The Middleware shall include moving averages module. The Contractor shall establish, test, deploy and troubleshoot the functionality of the moving averages module.

11.2.11.15. The moving average module should have real-time, failure notification capability and an autoverification interrupt function at the analyte, specimen, patient or instrument level.

11.2.11.16. The Middleware shall include Boolean logic rule writing applications and vendor developed drivers or functionality that enable the use auto-validation/auto-verification in accordance with CAP regulations.

11.2.11.17. The Middleware shall facilitate the development of compound, nested rules with multiple event actions.

11.2.11.18. The middleware rule-writing application should have a visual (point-&-click) graphical user

11.2.11.19. interface consistent with Microsoft Windows application and not require complex programming or coding. It should provide sufficient data elements & granularity so criteria can be defined for patient, specimen and test-level conditions.

11.2.11.20. The Middleware shall be able to query incoming orders and outgoing results and hold either for user review and action.

11.2.11.21. The Middleware shall contain a specimen management module that allows the user to quickly locate any specimen in the system.

11.2.11.22. The Middleware shall have the ability to transmit QC data directly to BioRad

Unity Real Time or any other comparable online Quality Control program.

11.2.11.23. The Middleware shall have a module for inventory management that facilitates the tracking of consumables and ordering of supplies, and include pertinent information about the consumables, including, lot numbers, expiration dates, and item numbers.

11.2.11.24. The server(s) must have sufficient memory to store all middleware records for a minimum of 14 days with downloading capability to an external medium for long term storage of patient records and other information.

11.2.11.25. The vendor shall provide an accessible online medium for long term storage for patient records, results and other information with storage capacity to maintain 2 years’ worth of information.

11.2.11.26. Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation.

11.2.11.27. Ability to retransmit patient records to universal interface system in case of interface outage.

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

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

11.2.11.30. “Hot Backup” server capable of taking over system functionality in event of primary server failure

11.2.11.31. Test Environment or Test Instance of the Middleware in order to be utilized as an isolated environment for testing new modules, configuration changes, instrument interfaces, upgrades, etc. Test System should have the ability to interface with VistA Test Account.

11.2.11.32. It is preferable that the vendor utilize the VA national site-to-site VPN or work with the VA Officer of Cyber and Information Security and Information Security Officers to establish a client-based VPN.

11.2.11.33. Provide a completed copy of the Manufacturer Disclosure Statement for Medical

Device Security (MDS2) and VA Form 6550.

11.2.11.34. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

11.2.11.35. 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.

11.2.11.36. The Contractor shall provide all hardware, software, lines, adapters, and devices required to connect all Laboratory instruments to the Middleware, including, but not limited to, Lantronix devices or equivalent that are capable of converting DB9 serial to RJ45 Ethernet following RS232 protocols.

11.2.11.37. The Contractor shall provide 24/7 technical support for all hardware and software of the Middleware and its’ connections.

11.2.11.38. The Contractor shall provide all updates, upgrades, revisions, patches, and fixes at no cost to the Contracting Officer.

11.2.11.39. The Contractor shall provide all necessary information to complete an ISA/MOU, if necessary, to create a VPN for the contractor to directly connect to the Middleware for troubleshooting purposes.

11.2.11.40. The Contractor shall provide all necessary licenses and support for licenses in order for the Laboratory to optimize the utility of the Middleware; i.e. licenses for connections and Thin Client licenses.

11.2.11.41. Remote access to server for multiple VA users, either with dedicated thin client terminals or via Windows Remote Desktop Connection

11.2.11.42. The Contractor shall provide training for the Middleware prior to implementation, annually thereafter and anytime there is an upgrade where additional training would be beneficial.

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

11.2.12.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. See Attachment A for current specifications.

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

11.2.12.3. 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).

11.2.12.4. 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 archive 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. The UPS is to be maintained by the Vendor.

11.2.12.5. If the proposed instrument system requires an independent water system to operate, the manufacturer will offer an option to include the water system and all maintenance of the system as part of the CPRR package.

11.2.13. Specific Equipment Requirements- -

11.2.13.1. Single lot of reagent for each test/analyte per shipment with a minimum dating of

90 days.

11.2.13.2. Patient testing is disabled if QC failure occurs.

11.2.13.3. The printer should be user defined to print the results real-time or on demand as well as option to print exceptional reports held in the middleware for autoverification purposes.

11.2.13.4. All equipment needed, analyzers, track, storage unit, etc must fit in the existing footprint of the current Chemistry equipment with no construction needed.

11.2.14. Method Performance/Validation Requirements

Method performance/comparison shall be at the expense of and performed by 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.

All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids as applicable. All studies must be approved by the local

Laboratory Medicine Medical Director and made electronically available. These requirements shall be in effect during installation and any future changes to the test menu and/or method updates.

11.2.14.1.1. Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run by 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.

11.2.14.1.2. 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 minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

11.2.14.1.3. Precision study using normal and abnormal control material. This shall include, at a minimum, within-run precision study of 10 normal and 10 abnormal controls. Intra-VISN facility variations should be kept at an absolute minimum.

11.2.14.1.4. Sensitivity. Sensitivity may be validated concurrently with correlation studies.

Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.

11.2.14.1.5. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

11.2.14.1.6. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation, if required. 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.

11.2.15. 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:

11.2.15.1. 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 individual references 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.

11.2.15.2. 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.

11.2.15.3. 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.

11.2.16. 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.

11.2.17. Support Features-

11.2.17.1. 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.

11.2.17.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, linearity materials, 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 validate 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 and electronic copy of data in an organized, clearly comprehensible format.

11.2.17.3. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services 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 key operator training for 2 operators per instrument, 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 instrument 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.

11.2.17.3.1. In addition, basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable.

11.2.17.4. 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:

11.2.17.4.1. Service Requirements

11.2.17.4.1.1. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of 1 hour

11.2.17.4.1.2. Equipment repair service shall be offered 24/7 for the medical center. Core business hours: Monday- Sunday, 24 hours a day including federal holidays.

11.2.17.4.1.3. 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 24 hours.

11.2.17.4.1.4. Remote Access diagnostic trouble shooting capabilities available with a national

ISO Internet Security agreement.

11.2.17.4.1.5. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

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

11.2.17.4.1.6.1. date and time notified

11.2.17.4.1.6.2. date and time of arrival

11.2.17.4.1.6.3. serial number, type and model number of equipment

11.2.17.4.1.6.4. time spent for repair, and

11.2.17.4.1.6.5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

11.2.17.5. 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 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.

11.2.17.6. 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 the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), printers and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

11.2.17.7. 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.

11.2.17.7.1. The determination and description shall address the following:

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

11.2.17.7.1.2. Waste ignitability (Reference 40 CFR §261.21)

11.2.17.7.1.3. Waste corrosively (Reference 40 CFR §261.22)

11.2.17.7.1.4. Waste reactivity (Reference 40 CFR §261.23)

11.2.17.7.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 C

FR §261.31)

11.2.17.7.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

(Reference 40 CFR §261.33)

11.2.17.7.1.7. Solid Waste (Reference 40 CFR §261.2)

11.2.17.7.1.8. Exclusions (Reference 40 CFR §261.4)

11.2.17.7.1.9. The contractor will provide written instructions and training material to ensure

11.2.17.7.1.10. VHA laboratory staff are trained as needed to properly operate devices with

11.2.17.7.1.11. 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.

11.2.17.7.2. 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 positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol 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:

11.2.17.7.2.1.1.1.1. Barium (Total)

11.2.17.7.2.1.1.1.2.

11.2.17.7.2.1.1.1.3. Cadmium (Total)

11.2.17.7.2.1.1.1.4. Chromium (Total)

11.2.17.7.2.1.1.1.5. Copper (Total)

11.2.17.7.2.1.1.1.6. Cyanide (Total)

11.2.17.7.2.1.1.1.7. Lead (Total)

11.2.17.7.2.1.1.1.8. Mercury (Total)

11.2.17.7.2.1.1.1.9. Nickel (Total)

11.2.17.7.2.1.1.1.10. Silver (Total)

11.2.17.7.2.1.1.1.11. Zinc (Total)

11.2.17.7.2.1.1.1.12. Arsenic (Total)

11.2.17.7.2.1.1.1.13. Selenium (Total)

11.2.17.7.2.1.1.1.14. Tin (Total)

11.2.17.7.2.1.1.1.15. pH

11.2.17.7.2.1.1.1.16. Flash point (to higher than 200 F)

11.2.17.7.2.1.1.1.17. BOD; biochemical oxygen demand

11.2.17.7.3. 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

11.2.18. 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.

11.2.18.1. 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.

11.2.18.2. 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]

11.2.18.3. 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.

11.2.18.4. 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.

11.2.19. 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.

11.2.20. 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.

11.2.21. The Contractor will identify if removable media is required to perform their duties. The Biomedical 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.

11.2.22. 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 6500.1, Electronic Media

Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA.

11.2.23. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic

Media Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the

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