36C25526Q0105.docx

SUBJECT*

VISN 15 | Hematology instrumentation, reagents, and service | CPRR |

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Contract Specialist Maria Riza R. Owen maria.owen2@va.gov

PLACE OF PERFORMANCE

Multiple Facilities

(See attachment A)

POSTAL CODE

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Sources Sought Notice This is not a request for formal proposals or quotes; it does not oblige the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing.

The purpose of this Sources Sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potentially qualified businesses interested in and capable of providing the required services.

Documentation of technical expertise must be presented in sufficient detail for the government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition.

Responses to this notice shall include the following:

(a) company name

(b) address

(c) point of contact

(d) phone and email

(e) UEI number

(f) Cage Code

(g) Type of small business, e.g., Services Disabled Veteran Owned Small Business, Veteran-Owned Small Business, 8(a), HUBZone, Women Owned Small Business, Small Disadvantaged Business, Small Business, or Large Business; and

(h) Capability statement that addresses the organization’s qualifications and ability to perform as a contractor for the work described below.

This Sources Sought is for the VISN 15 VA Medical Centers who have a requirement for Cost per Patient Reportable Result (CPRR), Hematology Instrumentation, reagents, and service.

The NAICS Code is 334516 with a Small Business size standard of 1,000 Employees.

All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). Additionally, all Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the SBA VetCert at https://veterans.certify.sba.gov/ Offerors capable of providing this service shall notify the Contract Specialist no later than (NLT) December 26, 2025, 1:00 pm CST via email at maria.owen2@va.gov.

All information is to be submitted via email to: maria.owen2@va.gov. Phone calls will not be accepted.

Sources Sought Notice

STATEMENT OF WORK

1. AGREEMENT LANGUAGE

INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish an agreement for Automated Hematology Instrumentation. The Government will award a CPRR to a single Contractor for Hematology instrumentation, reagents, and service. Contractor agrees to the following terms of the agreement exclusively with the VISN 15 facilities listed by Attachment A herein and awarded in the final agreement.

As requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the award as new technology becomes available on the market.

VISN 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. CPRR price will include all components (reagent, equipment, data manager system, hardware, software, service, etc.) necessary to allow for release of a test result into the VISTA computer system.

VISN 15 intends to establish the base year of the agreement for the period of 10/1/2026 through 9/30/2027.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. SCOPE OF PROCUREMENT:

A. All VISN 15 laboratory sites are currently equipped with XN analyzers. However, there is a need to replace these units with updated models. Specifically, the St. Louis VAMC, Kansas City VAMC, and Columbia VAMC each require one replacement XN3100 analyzer and one XN20 analyzer to replace the other existing XN3100 unit. (see attachment A) 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 capability to perform testing 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).

B. Equipment is located at the VISN lab facilities listed in Attachment A.

C. Preferred analyzer(s) shall be able to simultaneously perform the complete panel as defined by each facility in Attachment A.

D. If Contractor offers a family of analyzers, VISN technical evaluation panel will determine if instrumentation proposed meets needs of each participating facility.

E. 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 or 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. Estimated volumes of testing can be found in Attachment A.

F. 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.

G. Need validation of new equipment completed 60 days before end of previous contract (October 1, 2026).

H. Hematology analyzer must be able to directly connect with CellaVision digital imaging device to reduce technologist handling of sample tubes, blood, and slides.

I. For labs requiring total automation, proposed analyzer must have option for connectivity to an integrated clinical laboratory robotics system (automated track or connectivity). Automated repeat and/or reflex testing based on established rules developed by the laboratory. Desired specimen archival though mapping of specimens to racks.

2.2. DEFINITIONS:

A. 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 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.

B. 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.

C. 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.

D. Parameter definitions

1. CBC- Complete Blood Count

2. WBC- White Blood Cell Count

3. Diff- Automated Differential (Percent and Absolute)

4. RBC- Red Blood Cell Count

5. MCH- Mean Corpuscular Hemoglobin

6. MCV- Mean Corpuscular Volume

7. MCHC-Mean Corpuscular Hemoglobin Concentration

8. RDW- (SD & CV) - Red Cell Distribution Width

9. MPV-Mean Platelet Volume

10. RET – Reticulocyte Count

11. nRBC – Nucleated Red Blood Cell

12. IRF – Immature Reticulocyte Fraction

13. IPF – Immature Platelet Fraction

14. HGB – Hemoglobin

15. HCT - Hematocrit

16. PLT – Platelet Count

17. Complete Blood Count (CBC) and White Blood Cell (WBC) Automated

18. (DIFF) and Reticulocyte.

19. CBC with six-part WBC Diff shall include the following FDA approved parameters at a minimum; hemoglobin, hematocrit, WBC, RBC, platelet, MPV, MCH, MCV, MCHC, RDW-SD, RDW-CV, MPV, RET%, RET absolute, RET-He, and nRBC. The Six-part Diff shall include at a minimum: % neutrophils, % lymphocytes, % monocytes, % eosinophils, % basophils, % Immature Granulocytes%, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, and absolute immature granulocytes.

20. For the sites using the XN20, the WPC channel eliminates false positive slides generated from the Blast/Atypical Lymph (BAL) flag.

21. All associated software necessary for the pre-classification of white blood cells.

22. Pre-characterization of red blood cells.

23. Capability of obtaining a platelet estimate.

24. Systems should provide the ability to physically connect directly to a digital imaging device to reduce technologist handling of sample tubes, blood, and slides.

25. A fully integrated automated system with direct connectivity to a Slide processing system and digital image pre-classification of cells from start to finish. Allowing technologists to walk away and return with the capability to perform review, edit, and complete differential results without technologist intervention of moving slide from slidemaker/stainer to cell image identification system.

26. The ability for electronic remote slide review with other sites.

27. Reticulocyte count shall include the following parameters at a minimum: Absolute Reticulocyte count, Reticulocyte Count, Immature Reticulocyte Fraction.

E. Body Fluid analysis which is FDA approved for WBC, RBC and Total nucleated count with a 2-part WBC differential.

1. A separate mode on system for analysis of body fluids is preferred.

2. Must be able to analyze and report results from the following type of body fluids: Serous, Synovial, and CSF and are FDA approved on the analyzer.

3. The Total Count shall include the direct count for the White Blood Cell and/or Nucleated Cell.

F. Test Menu: Refer to Attachment A for desired test menu and estimated annual volumes.

2.3. GENERAL REQUIREMENTS:

A. Primary Analyzer(s): Base equipment offered shall fully support the scope of operations. Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, two mirror-image analyzers to act equally as primary analyzers are required to meet the productivity specifications defined herein.

B. Operational Features- The instrumentation offered shall have the following:

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

2. Ability to perform either a five (5) or six (6) part differential.

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

4. 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.

5. A bi-directional, bar-coded computer interface compatible with the current VA system (including middleware and Data Innovations to Vista), and Oracle Health EHRM later (expected during the term of this contract). The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

6. The accuracy of the barcode reading must have less than a 1% failure rate.

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

8. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric depending on site.

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

10. Minimal daily, monthly, and periodic maintenance.

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

12. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) months for reagents.

13. No requirements for sample pre-treatment.

14. Capability to detect out of range quality control.

15. Ability to accept various types of sample containers.

C. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

1. On-board QUALITY CONTROL data management system with a minimum storage capacity of 11 Quality Control files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

2. Fully reportable, FDA cleared 6-part differential, including immature granulocyte enumeration to reduce the need for manual differential.

3. For requesting sites, preferred analyzer/instrument will be able to allow for separation of blast cells and abnormal lymphocytes from normal, mature cells to provide more accurate differential flagging. If more than analyzer is requested per site, only one of the analyzers should have the additional abnormal flagging capability. Multiple analyzers do not need to provide the abnormal flagging capability.

4. Analyzer must have the ability to document on analyzer Quality Control review and corrective action documentation.

5. Remote monitoring capabilities to include instrument monitoring (and appropriate notification to site of issues/concerns with analyzer functionality) and Quality Control upload and management. This option must have National ISA/MOU approval with documentation for analyzer being proposed. Remote monitoring must be currently in use by other VA facilities.

6. Analyzer must have the ability to perform testing on Body Fluids. This process must be FDA approved.

7. On board reagent inventory system.

8. Only one mode calibration required for all functions of the analyzer.

9. Minimal carryover.

10. Manufacturer controls are preferred. Third party controls are acceptable and shall be supplied by vendor and included in the proposed CPRR price.

11. Calibration stability for a minimum of 6 months. Ability to calibrate in all sample modes. Calibration kits shall be supplied by the vendor.

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

1. A main computer backup system must be provided.

2. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. The size limitations for this is 12 feet by 4 feet for sites receiving two primary analyzers and 15 feet by 4 feet for sites receiving two primary analyzers and slide maker stainer.

3. An on-board monitor/screen that is easily readable.

4. A printer 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). (Minimum of a 10-character specimen identifier). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract.

5. An uninterruptible power supply with line conditioner for each analyzer/instrument provided under this contract. Replacement uninterruptible power supply with line conditioners shall be provided as needed, at no additional charge, for the duration of the contract. Replacement batteries will be provided for the power supply, at no additional charge, for the duration of the contract.

6. An auto sampling system that includes cap piercing closed tube aspiration, auto- loader, and auto-mixing.

7. Primary tube sampling.

8. Clot detection.

9. Manual sampling mode that reads barcode label; ideally both closed and open manual sampling modes is desirable.

10. Slide maker/stainer option available for sites that listed on Attachment A.

11. Ability for laboratory to customize rules for differential or morphology review.

12. If system runs on Windows, ability to run Windows 10 and Windows 11.

13. Option for an Integrated Clinical Laboratory Hematology Analyzer and Robotics System (Automated track or Connectivity). Automated repeat and/or reflex testing based on established rules developed by the Laboratory. Desired specimen archival through mapping of specimens to racks; for easy retrieval once moved off-line.

14. For sites requesting a slide maker/stainer, the following requirements must be met;

· Slide making capability must include slide identification and selective staining according to user-defined criteria.

· Slide staining must produce consistent high quality-stained slides.

· Integrated slide maker/stainer must have capability of labeling the slide with the unique identifier number and date to comply with regulatory agencies.

· Slide maker/stainer must be available to both the primary and the co- analyzers.

· Preferred Vendor to supply Slide-maker/Stainer reagent/supplies such as all buffers, slides, ribbons, and stain. If multiple types of buffers or stains are required, all types are provided in contract.

· If site requires, slide maker/stainer should be physically connected as well as integrated with analyzer decision rules to reduce operator hands-on, improve turn-around time, and reduce potential for error or injury or infection from handling tubes of blood.

· System must have Slide maker/stainer connectivity to analyzer without technologist intervention when it is determined a slide is required.

15. For site requesting an Automated Digital Cell Morphology System, the following requirements must be met.

· All associated software necessary for the pre-classification of white blood cells

· Pre-characterization of red blood cells

· Capability of obtaining a platelet estimate.

· System should provide the ability to physically connect directly to a digital imaging device to reduce technologist handling of sample tubes, blood, and slides.

· A fully integrated automated system with direct connectivity to a Slide processing system and digital image pre-classification of cells from start to finish. Allowing technologists to walk away and return with the capability to perform review, edit, and complete differential results.

· The ability for electronic remote slide review with other sites

· Remote viewing on multiple personal computers (PC), if available

· Slide scanning unit

· Provide Middleware system for review of images, if applicable.

· Slide scanning unit and all associated software necessary for the pre-classification of white blood cells, pre-characterization of red blood cells, and manual estimation of platelet concentration.

· System has a designated computer that runs the software and includes a laser/inkjet

· Remote viewing on multiple personal computers (PC), if available.

· Analyzers need ability to connect to the VA computerized hospital information system.

E. Interface Requirements

1. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A).

2. The vendor shall provide assistance with setting up Autoverification through Data Innovations

· Work with the Laboratory LIMs to interface VISTA LIS and Oracle-Cerner with vendor provided instruments

· Provide remote or onsite guidance on validation techniques and assist troubleshooting

· Provide support and guidance during modifications of final Autoverification build. For example, modifying rules logic cutoff based on evolving SOP’s.

3. 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.

4. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

5. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

6. 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.

7. Contractor shall provide copies of current ISA/MOU and BAA with the VA that are applicable for remote connection to the interface system used to manage the testing system.

F. Method Performance/Validation Requirements

1. 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.

2. 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.

3. 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.

4. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept at an absolute minimum.

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

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

7. 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:

8. A verification of the manufacturer’s suggested reference range may be performed if 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 at each VISN 15 location to verify the manufacturer’s range. Any apparent outliers should be omitted, and new specimens obtained to provide a statistically valid verification.

9. 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.

10. 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. 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.

12. Internal Barometer Check. If the instrument has an internal barometer, its function should be checked by comparing its values to a reliable independent measurement on installation and per the manufacturer’s guideline. This check should be performed by the vendor.

G. Support Features

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. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format at no cost to the Government.

3. Training. The Contractor shall provide instrument training program that is coordinated with and timely to the equipment installation and appropriate for the size and scope of the facility’s services. This shall include detailed, hand-on training on the operation of the system, data management, maintenance, quality control, limitations of tests, data manipulation, and basic troubleshooting and repair. When training occurs on-site, all operators performing testing will be trained by the contractor. When such training occurs off-site, it will include two operators per analyzer in the first year. Thereafter, the Contractor shall provide off-site 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. There shall be no difference in the detail of training provided on-site and off-site.

H. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

1. Service Requirements

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

· Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. 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.

· repair response time shall be no more than 24 hours.

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

· 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:

i. date and time notified

ii. date and time of arrival

iii. serial number, type and model number of equipment

iv. time spent for repair, and

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

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

3. 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 agreement; however, it does refer to significant changes in the hardware operational capability.

4. Ancillary support equipment - the contractor shall provide, install and maintain through the life of the agreement , as indicated, any and all ancillary support equipment to fully operate or place the analyzer within a laboratory as defined in these specifications, e.g. carts or stands to support/house the analyzer, water systems (including consumable polishers, filters, etc.), 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, line conditioners, UPS and UPS Batteries etc.

5. 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 agreement. Attachment C may be used as a template to provide these quarterly reports.

6. Waste Stream Specifications

· 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.

7. The determination and description shall address the following:

· Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

· Waste ignitability (Reference 40 CFR §261.21)

· Waste corrosivity (Reference 40 CFR §261.22)

· Waste reactivity (Reference 40 CFR §261.23)

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

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

· Solid Waste (Reference 40 CFR §261.2)

· Exclusions (Reference 40 CFR §261.4)

8. 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.

9. 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, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation must include, but not be limited to the concentration/measures of the elements and parameters listed below:

· pH

· Flash point (to higher than 200F)

· BOD; biochemical oxygen demand

10. 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 the waste from each device can legally be disposed of via the sewerage system

11. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than days after the award of the agreement. this timeline is based on a reasonable attempt of the contractor to complete all the necessary implementation requirements within the stated timeframe. contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the contractor and is a result of delays due to the government.

12. Upon award of an agreement, the transition period for the awarded agreement to have all equipment and peripherals installed and operational by January 1, 2027. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

13. Contractor shall provide with its quotation an implementation plan for installation of new equipment. contractor’s submitted plan shall project for the transition of all services under the awarded agreement including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations with a start date of October 1, 2026. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate agreement for cause under the Termination for Cause clause of the agreement.

14. October 1, 2026, the awarded Contractor shall have full and sole responsibility for services under the awarded agreement.

See attached document: Hematology Attchment A 2026 12.10.2025 ILW.

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