Statement of Work

Molecular Testing Instrumentation for Amarillo VA Health Care System

SCOPE

Amarillo VA Health Care System and its Community Based Outpatient Clinics (CBOCs) located in Lubbock, TX; Dalhart, TX; Childress, TX; and Clovis, NM, are in need of replacement analyzers to perform molecular testing on our patient population. The PCR system/analyzer shall have the capability of identifying the nucleic acid of targeted pathogens. The analyzers shall be able to integrate sample preparation, amplification, detection and analysis 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). The instrument must be approved by the Food and Drug Administration (FDA). Our current analyzers contract will end 09/30/2026 and a new contract is needed, with instruments validated and ready to run patient samples on 10/01/2026. The vendor shall provide a Cost Per Reportable Result (CPRR) program to include the equipment, service, consumables, reagents, controls, and calibrators necessary to operate system(s). This CPRR program will not include tubes and paper. Training and associated expenses for up to two (2) key operator(s) per instrument is included.

Amarillo VA Health Care System Clovis VA CBOC 6010 Amarillo Blvd., West 921 E. Llano Estacado Blvd.

Amarillo, TX 79106 Clovis, NM 88101

Lubbock VA Clinic Childress VA CBOC 3510 4th Street 2305 Avenue F NW Lubbock, TX 79415 Childress, TX 79201

Dalhart VA CBOC 325 Denver Ave.

Dalhart, TX 79022

TYPE OF CONTRACT

This is firm Cost per Patient Reportable Result (CPRR) fixed contract for Indefinite Delivery/Indefinite Quantity (IDIQ) to include all reagents, calibrators, consumables, and services to be delivered upon the ordering facility.

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.

The Vendor must provide all equipment, reagent, calibrators, controls, consumable items, parts, accessories, ancillary devices, software updates and upgrades, service plans, shipping costs, installation, validation studies, training, and any other item required to establish instrument operation, and should be from the same family of analyzers as applicable and suitable for the facilities listed.

EQUIPMENT REQUIREMENTS

1. Specification of component equipment as set forth in this section are minimum specifications, unless otherwise stated, and shall not be construed as limiting the overall quality, quantity, or performance characteristics of items furnished in the system. The Contractor Furnished Equipment (CFE) shall meet or exceed the minimum requirements and shall be held responsible for the supply, performance, and overall quality of the contractor’s furnished equipment.

2. All equipment to be supplied under this specification shall be the newest and the most current model of standard product of a manufacturer of record. A manufacturer of record shall be defined as a company whose main occupation is the manufacture for sale of items of equipment and which:

a. Maintains a factory production line.

b. Maintains a stock of replacement parts for the item.

c. Maintains engineering drawings, specifications, operating manuals, and maintenance manuals.

d. Has published and distributed descriptive literature and equipment specifications on the equipment.

3. Molecular testing equipment must meet the following specifications:

a. The vendor shall provide each facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing. Tests shall be vendor supported. The analyzer must be able to perform all assays listed.

b. It is random access instrument.

c. Must allow rapid identification of pathogens from laboratory samples with a turnaround time of 90 minutes or less.

d. The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as, but not limited to, printer, UPS, interface boxes and surge suppressors.

e. Must meet performance and characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

f. Bi-directional, bar-coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system/and or Cerner LIS system for real time data transmission. Interfacing requirements to be provided by the vendor:

I. Instrument LIS physical connection and translation (drivers). Must be compatible with Data Innovation, VistA, and Cerner Information Systems.

II. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer.

g. The total equipment footprint, when installed, must not negatively impact the functionality/operations of the Pathology & Laboratory Service nor will it require significant and/or costly infrastructure changes. The available space is 96 inches wide x 30 inches deep at Amarillo and Lubbock laboratories and 50 inches wide x 30 inches deep at the Clovis, Dalhart, and Childress CBOCs.

h. Printer with capability of printing a chartable patient report with the complete patient results on a single sheet.

i. Uninterruptible power supply for the analyzer.

j. Analyzers at the Childress, Clovis, and Dalhart VA CBOCs must be waived with no sample preparation necessary or minimal sample preparation.

k. Analyzers at the Amarillo VA or Lubbock VA can be waived or non-waived with no sample preparation necessary or minimal sample preparation.

l. System shall accept throat, nasal samples, and other body fluids.

m. System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency.

n. The system must have the ability to conduct the test and give results rapidly

(measured within ninety minutes including preparatory time).

o. System shall have a design that removes the possibility of reagent and sample carryover, or at the very least have a mechanism in place that notifies the technician of possible carryover.

I. Carryover studies shall be performed, if applicable, as part of the initial evaluation of the instrument.

II. Vendor shall provide interpretation of raw data the instrument installed.

III. Vendor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. System must have documented evidence that there is no carryover interference with other onboard assay.

n. The analyzers must have a QC program for all tests which includes at a minimum the following options.

I. The ability to view and print daily and monthly QC results.

II. QC acceptance criteria built in.

III. QC data storage.

o. Equipment shall be able to store and retransmit records (at least 24 hours) in case of interface downtime. Must have the ability to backup and store patient data on external media.

p. Testing equipment must be new, state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

q. Must be able to perform PCR assays listed below:

I. Strep A

II. CT/NG

III. Influenza A/B

IV. RSV

V. MRSA

VI. C diff

VII. Vaginal Panel

r. Vendor shall list the reagents and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution.

s. Vendor shall list the reagents/waste receptacles requiring treatment before disposal. Vendor shall also list all reagents/waste that is considered above normal toxicity and/or hazardous.

t. Instruments must have a 120–220-volt UPS system provided.

INSTALLATION AND VALIDATION

1. Vendor shall move instruments, free of charge, to final testing location upon completion of validation process.

a. Due to this procurement occurring during the remodel of the Amarillo VA laboratory, the vendor shall move instrument(s), free of charge, to the new laboratory.

b. Should validations be required due to the move to a new location, the vendor shall perform these as well, free of charge.

2. Vendor shall provide the facility with all cross-over supplies and reagents needed at installation, and during training of staff. Test counts for billing will begin after review/approval of all correlation studies performed at installation.

3. The vendor shall provide all installation/set-up and when bringing new tests on-line, a technical support specialist who shall perform all validation studies including installation/setup, correlation studies (evaluation/comparison data sufficient to satisfy regulatory standards such as CAP), staff training, in-service to laboratory personnel and clinicians, and assist with any methodology problems and questions. This service shall be available during regular office hours (0800-1700) on a 5 days/week basis.

4. Throughout the life of the agreement, the vendor shall provide assistance to the user with setup, validations, maintenance, software upgrades, and troubleshooting assays as additional tests are identified and utilized.

5. Implementation plan of ≤ 90 days. Must complete installation, training, validation within ≤ 90 days.

TRAINING

1. The vendor shall provide key operator training for a minimum of two users per instrument with on-site training available to remaining users on all tours with competency assessment performed and documented.

2. Vendor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals (also available electronically). Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) format.

BILLING AND INVOICING

1. Monthly billing and test report summaries shall begin on the first day of the month and include the last day of the month.

2. VA-FSC shall require the following information in compliance with the Prompt Pay Act and Business Requirements:

a. Your Taxpayer ID number (TIN).

b. Your “Remit Address" information.

c. The VA Purchase Order (PO) number.

d. Your contact information: (Personal Name, Email, and Phone).

e. Your VA Point of Contact information (Personal Name, Email, and Phone).

f. The Period of Performance Dates (POP Beginning and Ending).

g. All discount information if applicable (Percent and Date Terms).

h. Reagents used with pricing per unit.

i. No freight charges are to be added to the invoice.

3. AVAHCS shall not be responsible for payment of service and/or supplies which were not requested in accordance with the contract.

4. AVAHCS will NOT pay for tests that are not clearly identified by product number on the invoice.

5. Invoices are to be separated for Amarillo and Lubbock laboratories, but the usage of the same PO number is acceptable for billing purposes.

6. All invoices submitted through Tungsten to VA-FSC should mirror your current submission of Invoice and shall match final contract pricing.

HOURS OF OPERATION

1. Normal hours of operation are listed below, excluding holidays:

Amarillo, TX VA: 8:00 am to 4:30 pm (CT) Lubbock, TX VA: 8:00 am to 4:30 pm (CT) Dalhart, TX VA CBOC: 8:00 am to 4:30 pm (CT) Childress, TX VA CBOC: 8:00 am to 4:30 pm (CT) Clovis, NM VA CBOC: 7:30 am to 3:30 pm (MST)

2. All work will be performed during normal hours of coverage unless requested or approved by laboratory supervisor or their designee.

3. Federal Holidays observed by the VAMC are:

New Years’ Day Martin Luther King Day Presidents’ Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans’ Day Thanksgiving Day Christmas Day

4. Equipment repair response time shall be no more than 24 hours.

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.

6. A malfunction incident report shall be furnished upon completion of each repair call.

The report shall include, at minimum, the following: date and time notified, date and time of arrival, serial number, type and model number of equipment, time spent on repair, and proof of repair to include documentation of a sample run of quality control verifying acceptable performance.

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

8. Vendor shall not access patient information during service and/or repairs.

SERVICE AND MAINTENANCE

1. Instrument support service shall aid with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours. The support service shall follow up all downtime calls within 1 hour.

2. The vendor shall provide a twenty-four hour/seven-day service hotline with technical support.

3. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventive maintenance visits as required.

4. The vendor shall supply engineering controls if necessary for any heat, humidity, or noise issues that may result from use of the proposed system.

5. Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g., upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).

6. Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level.

7. For reagents with hazardous constituents, vendor shall provide a mechanism for the laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals.

INTERFACE

1. Transfer of data is bidirectional. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

2. Equipment must accept, at a minimum, 10 characters in specimen identification.

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

4. The following data fields will be collected:

Prime ID Specimen ID Patient ID Priority Action Code Sample Type Collect Date Collect Time Creation Date Middle Name Last Name First Name Location Sex Birthday Test Name Analyzer Station

5. Data is transferred from VistA to a Data Innovations Middleware (DI) device which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the DI which then sends the result back to VistA in the appropriate format.

6. All testing is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access, and verify codes. VA sensitive information is stored in the VISTA/LIS database, and all reports are backed up on disk and stored in a secure, location per regulations. Data will be available using CPRS system.

7. The above Personal Private Information (PPI) will stay on the instrument’s hard drive for about one month and then will be “written” over by new patient data. At the end of the contract, the hard drive and any other data storing devices will be removed from the instrument and taken to IRM for disposal.

OTHER

1. Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the order. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria satisfactorily to the user.

2. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor’s equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer.

3. The vendor shall reimburse the facility of any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other vendor related factors.

The damage assessed shall be applied to the invoice in the form of a credit or deduction.

4. If any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor’s equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.

5. This order should assist the Department of Veterans Affairs to pursue the goal of being a good steward in our community by eliminating, minimizing, or mitigating adverse environmental impacts.

6. The following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents and in what concentration that contain the following chemicals:

1,1,1-Trichloro-ethane Benzene Cadmium Carbon tetrachloride Chloroform Chromium Cyanide Dichloromethane Lead Mercury Methyl ethyl ketone Methyl isobutyl ketone Nickel Tetrachloro-ethylene Toluene Trichloro-ethylene Xylenes

COMPLIANCE WITH THE GENERAL SAFETY REGULATIONS

1. All Contractors and Subcontractors performing services for the Government shall comply with all Occupational Safety and Health Administration (OSHA), State, County and Municipal Safety and Occupational Health Standards and any other applicable rules and regulations. Also, all Contractors and Subcontractors shall be held responsible for the safety of their employees and any unsafe acts or conditions that may cause injury or damage to any person or property within and around the work site area under this contract.

2. All ladders, scaffolding, tools, equipment, personal protective equipment, etc. shall be OSHA approved for the work to be performed. Contractors shall use caution signs as required by OSHA Regulations. Caution signs shall be on-site on commencement of Contract.

3. The Contractor shall purchase and issue all chemicals in their original containers.

Materials that require precautionary warnings shall be affixed to all containers such labels or markings as are prescribed by law, regulatory agencies or this contract.

Any violation of OSHA may be subject to default action.

4. Contractor shall furnish to the COR two (2) copies of Safety Data (SDS), for all products proposed for use, a minimum of seven (7) days prior to beginning service, for approval. Contractor must update copies of the SDS on an annual basis. In addition, each time a new chemical product is proposed to be introduced into the facility, a copy of that product’s SDS must be provided to the COR for approval, prior to the product being used at the facility.

IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS

1. The Contractor’s FSEs shall always wear visible identification while on the premises of the VAMC. It is the responsibility of the contractor to obtain and pay for parking.

The VAMC does not provide any parking. The VAMC will invalidate or make reimbursement for parking violations or charges for the Contractor under any conditions. Smoking is prohibited inside any building at the VAMC.

2. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

CONFIDENTIALITY AND NONDISCLOSURE

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the Vendor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the Vendor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO in response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

CONTRACTOR SECURITY REQUIREMENTS

1. The Vendor requires no access to AVAHCS or any VA information system. The vendors analyzers will be compatible and interfaced with the AVAHCS information system. There will be supervised access when the Vendor is physically present for technical support, service calls, and scheduled preventative maintenance.

2. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

3. The C&A requirements do not apply. A Security Accreditation Package is not required.

(End of Statement of Work)