36C25226Q0102.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

None

36C25226Q0102 11-26-2025

Colby Pasholk Email Only 12-10-2025

10:00AM CST

36C252

Department of Veterans Affairs

36C252

115 South 84th Street, Suite 101

Milwaukee WI 53214-1476

X

334516

1000 Employees

NET 30 DAYS

N/A

X

36C695

Clement J. Zablocki VA Medical Center

Lab Room 2600

5000 W. National Ave

Milwaukee WI 53295-1000

36C252

Department of Veterans Affairs

36C252

Great Lakes Acquisition Center - HC

115 South 84th Street, Suite 101

Milwaukee WI 53214-1476

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

This solicitation is for a Brand Name or Equal 10-color

Flow Cytometry instrumentation with ancillary sample/reagent prep equipment. This can be a CPRR (Cost per Patient

Reportable Result), CPT (Cost per Test), or fixed monthly lease.

Facility Address:

Clement J. Zablocki VAMC

Lab Rm. 2600

5000 West National Ave.

Milwaukee, WI 53295-1000

Base Plus four option periods

BASE: 08/01/2026-07/31/2027

OY 1: 08/01/2027-07/31/2028

OY 2: 08/01/2028-07/31/2029

OY 3: 08/01/2029-07/31/2030

OY 4: 08/01/2030-07/31/2031

See Section B for more information

See CONTINUATION Page

X X

X 1

Parris Weidenbach

Contracting Officer

36C25226Q0102

SECTION B - CONTINUATION OF SF 1449 BLOCKS

SECTION B - CONTRACT ADMINISTRATION DATA

B.1 CONTRACT ADMINISTRATION

All contract administration matters will be handled by the following individuals:

A. CONTRACTOR: ________________________________ (Contractor’s Name)

________________________________ (Address)

________________________________ (City-State-Zip)

________________________________ (Point of Contact/Title)

________________________________ (Phone/FAX Number)

________________________________ (E-Mail Address)

________________________________ (SAM UEI)

B. GOVERNMENT: COLBY PASHOLK, CONTRACTING OFFICER

DEPARTMENT OF VETERANS AFFAIRS

GREAT LAKES ACQUISITION CENTER

115 S. 84TH ST., SUITE 101

MILWAUKEE WI 53214-1476

EMAIL: COLBY.PASHOLK@VA.GOV

B.2 CONTRACTOR REMITTANCE ADDRESS

All payments by the Government to the contractor will be made in accordance with:

52.232-33, Payment by Electronic Funds Transfer - System for Award Management

B.3 INVOICES

Invoices shall be submitted in arrears in accordance with:

a. 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

b. UPON ACCEPTANCE OF ITEMS

B.4 GOVERNMENT INVOICE ADDRESS

All invoices from the contractor shall be submitted electronically in accordance with 852.232-72

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

FACSIMILE, E-MAIL, AND SCANNED DOCUMENTS ARE NOT ACCEPTABLE

FORMS OF SUBMISSION FOR PAYMENT REQUESTS.

For assistance setting up e-Invoice, the below information is provided:

* Vendors must register online at http://www.tungsten-network.com/veteransaffairs/

* Tungsten Network Setup Information: 1-877-489-6135

* Tungsten Network email: VA.Registration@tungsten-network.com

* FSC Vendor Support Section Contact: 1-877-353-9791

* FSC Vendor Support Section email: vafsccshd@va.gov

Vendors can inquire on the status of payments by accessing VIS at:

https://www.vis.fsc.va.gov/login.aspx?ReturnUrl=%2fDefault.aspx

INVOICES: Invoices shall be submitted in arrears:

a. Quarterly _______

b. Semi-Annually _______

c. Other X Upon Receipt of Equipment GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be mailed to the following address:

DEPARTMENT OF VETERANS AFFAIRS

FINANCIAL SERVICES CENTER

PO BOX 149971

AUSTIN, TX 78714-9975

Vendor inquires: Toll Free Number 1-877-353-9791

B.5 BASIS OF AWARD

The Government will make the award to the lowest price technically acceptable offer.

B.6 SECURITY & PRIVACY CONTROL

The Certification & Accreditation (C&A) requirements of VHA Handbook 6500.6 do not apply to this requirement; therefore, a Security Accreditation package is not required. No C&A or MOU/ISA is required. Sensitive information exposure as part of this contract involves applicable security controls within the facility as part of the VA Information Security Program.

If there are any questions related to privacy, please have a member of your staff contact the VA Privacy

Service at 202-461-6309. If there are any questions related to the information security, please have a member of your staff contact the Office of Cyber Security at 304-262-7733.

B.7 STATEMENT OF WORK

http://www.tungsten-network.com/veteransaffairs/ mailto:VA.Registration@tungsten-network.com mailto:vafsccshd@va.gov https://www.vis.fsc.va.gov/login.aspx?ReturnUrl=%2fDefault.aspx

VISN12 Pathology and Laboratory Medicine

Clement J. Zablocki VA Medical Center, Milwaukee, WI

1.0 LANGUAGE

1.1. INTENT: It is the intent of the Department of Veterans Affairs, specifically Clement J. Zablocki

VA Medical Center Laboratory located in Milwaukee, WI, to establish a contract for 10-color

Flow Cytometry instrumentation with ancillary sample/reagent prep equipment. This can be a

CPRR (Cost per Patient Reportable Result), CPT (Cost per Test) or a fixed monthly lease. This is not a capital purchase. The Government will award a contract to a single Contractor for Flow

Cytometry instrumentation. Contractor agrees to the following terms of the contract exclusively with the Clement J. Zablocki VA Medical Center

1.2. ELIGIBLE FACILITY:

1.3. Laboratory, Milwaukee, WI and awarded in the final contract. Additional tests, reagents, and instrumentation may be added to the contract as new technology becomes available on the market and added to the awarded contract.VISN 12 testing performed at:

Clement J. Zablocki VA Medical Center

5000 W. National Ave. – Lab Rm. 2600

Milwaukee, WI 53295

POCs will be provided to the Awardee.

1.4. ORDERS: This awarded contract does not obligate any funds. The Government is obligated only to the extent of authorized purchase orders issued under the awarded contract by authorized individuals.

1.5. PRICES AND TERMS: The Clement J. Zablocki VA Medical Center Laboratory will provide an estimated volume by test. The Government estimates the volumes but does not guarantee volumes as listed; they are estimates ONLY. The shipping of all reagents, consumables, and supplies shall be FOB Destination. See Attachment A for estimated yearly test volumes.

1.6. TERM OF AGREEMENT: 0. If the Contractor fails to perform in a manner satisfactory to the

CO (Government Contracting Officer), the awarded contract may be terminated within thirty

(30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This contract shall be reviewed annually.

1.7. IDENTIFICATION: Delivery orders issued shall be identified by the awarded contract number and the corresponding Purchase Order Number for the Clement J. Zablocki VA Medical Center

Laboratory.

1.8. ORDERING METHOD: The participating facility may order products via Electronic Data

Interchange (EDI), telephone, facsimile, or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2.0 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. SCOPE OF PROCUREMENT:

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

Standards Institute (CLSI).

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

2.1.3. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, consumables, and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the

Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory recalls and alerts, prior to or simultaneously with field alerts should be forwarded to the Contracting Officer and designated Points of Contact (POC) determined at contract award.

2.1.4. 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 or routine supplies delivery.

2.2. DEFINITIONS:

2.2.1. Cost per Patient Reportable Result (CPRR) - as defined in the Federal Supply Schedule

FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - The per patient reportable result price shall include costs covering: (1) 5-year equipment use. (2) All reagents, standards, quality controls, supplies, consumable and disposable items, parts, accessories and any other items 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 in producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory

Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition. This element includes both preventive maintenance and emergency repairs. (4) Training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

2.2.2. Cost per Test (CPT) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering: (1) 5-year equipment use. (2) All reagents, standards, quality controls, supplies, consumable and disposable items, parts, accessories and any other items 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. (4) Training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

2.2.3. Fixed monthly lease- The fixed monthly lease agreement shall include costs covering: (1)

5-year equipment use. (2) All reagents, standards, quality controls, supplies, consumable and disposable items, parts, accessories and any other items required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. This fixed monthly lease agreement price shall also encompass all costs associated with dilution, repeat, and confirmatory testing required in producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) All necessary maintenance to keep the equipment in good operating condition. This element includes both preventive maintenance and emergency repairs. (4) Training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

2.2.4. Parameter Definitions

2.2.4.1. Lymphocyte Subsets – Shall include the following parameters at a minimum:

Total T Lymphocyte percent (%) and absolute count (#), T Helper percent (%) and absolute count (#), T Suppressor percent (%) and absolute count (#), T Helper to T

Suppressor ratio, Total B Lymphocyte percent (%) and absolute count (#), Total

NK Cell percent (%) and absolute count (#).

2.2.5. 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, use, or disclose VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

2.3. TEST MENU

2.3.1. Instrument shall perform analysis of Lymphocyte Subsets (T/B/NK cells) and

Leukemia/Lymphoma Immunophenotyping. Minimal residual disease (MRD) testing is also planned to be added to the test menu. Samples used for analysis shall be whole blood, bone marrow, lymph nodes, and body fluids.

2.3.2. Refer to Attachment A for current panels and estimated annual test volumes.

2.4. GENERAL REQUIREMENTS:

2.4.1. Primary Analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and must meet all of technical specifications of this solicitation. The flow cytometer(s) shall be new; no refurbished equipment.

2.4.2. Two flow cytometer analyzers are desired.

2.4.3. Ancillary sample/reagent prep equipment – A stand-alone, automated/semi-automated sample preparation system capable of reagent addition, incubation, washing (if necessary) and fixative addition for Lymphocyte Subset sample preparation. The same or a separate stand-alone, automated/semi-automated sample preparation system of accurately pipetting samples, reagents, and 10-color antibodies and/or 10-color cocktails.

2.4.4. Operational Features – The instrumentation offered shall have the following:

2.4.4.1. The capability of performing Lymphocyte Subset and Leukemia/Lymphoma

Immunophenotyping assays. Minimal residual disease (MRD) testing is also planned to be added to the test menu.

2.4.4.2. A minimum of 10-color fluorescence with an additional 2 channels for light scatter properties.

2.4.4.3. Adequate lasers/filters with fixed optical alignment.

2.4.4.4. Temperature Control mechanism that can regulate internal temperature fluctuations.

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

2.4.4.6. Capable of mixing each sample tube before being delivered to the system.

2.4.4.7. FDA-approved system and software with ability to use a single platform for absolute counts for Lymphocyte Subsets (T/B/NK cells).

2.4.4.8. Windows-based operating system.

2.4.4.9. Bi-directional interface with hospital computer system.

2.4.4.10. Remote diagnostics capability, including remote laser alignments through software, to minimize lab downtime.

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

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

2.4.4.13. Equipment must accept, at a minimum, 15 characters in specimen identifier that is alpha and/or numeric depending on the site.

2.4.4.14. Minimal daily, weekly, monthly, and periodic maintenance. Minimal daily maintenance such that the analyzer is not required to be down for more than 60 minutes per day (this is not to exclude longer times for periodic maintenance).

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

2.4.4.16. 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.

2.4.4.17. Capability to detect out of range quality control.

2.4.4.18. A stand-alone, automated/semi-automated sample preparation system capable of reagent addition, incubation, washing (if necessary) and fixative addition.

2.4.4.19. A stand-alone pipetting system capable of accurately pipetting samples, reagents, and controls.

2.4.5. Technical Features – The instrument shall be approved by the Food and Drug

Administration and have the following:

2.4.5.1. Data Management System.

2.4.5.2. On-board QC data management system with a minimum storage capacity of 12 QC files and includes Levy-Jennings graphs.

2.4.5.3. Automatic and manual system compensation.

2.4.5.4. Capability of real time compensation, data analysis, and gating.

2.4.5.5. Fully digital electronics for linear, log, etc. for all collected parameters, with post-acquisition electronics.

2.4.5.6. The ability to create custom test panels.

2.4.5.7. Software for remote data analysis, manipulation, and interpretation by technologists and pathologists.

2.4.5.8. A quality control package used for daily monitoring of system performance and operator notification of QC failure.

2.4.5.9. Ability to use automated or manual sample introduction.

2.4.5.10. Minimal sample carryover <5%.

2.4.5.11. Adjustable flow rates.

2.4.6. Hardware Features

2.4.6.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

2.4.6.2. Equipment relocation and reinstallation should the equipment need to be removed due to construction or laboratory redesign at no additional cost for one (1) relocation.

2.4.6.3. Uninterrupted Power Supply (UPS) to provide uninterruptible electrical power without electrical voltage fluctuations. Replacement uninterruptible power supply with line conditioner shall be provided as needed, at no additional charge, for the duration of the contract.

2.4.6.4. A color printer that will print minimally two forms of patient identification on the test report. Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract.

2.4.6.5. Accurate barcode reading with less than 1% read failures.

2.4.6.6. A minimally 22-inch LCD Monitor.

2.4.7. Specific Equipment Requirements

2.4.7.1. A stand-alone, automated/semi-automated sample preparation system capable of reagent addition, incubation, washing (if necessary) and fixative addition for

Lymphocyte Subset sample preparation.

2.4.7.2. Option for a stand-alone pipetting system capable of accurately pipetting samples, reagents and controls for 10-color Leukemia/Lymphoma tube pipetting or cocktail preparation.

2.4.8. Method Performance/Validation Requirements

2.4.8.1. 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.

2.4.8.2. The contractor shall assist with performing method validation to include correlation study, analytical measurement range (AMR), precision, sensitivity, specificity, and carryover studies to demonstrate satisfactory instrument performance consistent with CLSI standards.

2.4.8.2.1. Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range, shall be run by the present and the proposed method.

Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of a mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

2.4.8.2.2. 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.

2.4.8.2.3. 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 a minimum of 10 days (may be run twice a day) for a total of at least 20 values per level of control.

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

2.4.8.2.5. Specificity studies. A review of product literature and assay inserts to determine any adverse effects for interfering substances.

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

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

2.4.8.2.7.1. 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 male and 20 female reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

2.4.8.2.7.2. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established.

Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

2.4.8.2.7.3. If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

2.4.9. Support Features

2.4.9.1. 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 or refurbished equipment are not acceptable.

2.4.9.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable and disposable items, parts, accessories, and any other item included on the list of supplies required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, 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 assist with statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

2.4.9.3. 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. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair. Thereafter, the

Contractor shall provide training for minimally one operator 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. The contractor shall provide training for two staff pathologists which shall consist of software usage and data manipulation.

2.4.9.4. 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 and any incremental support equipment, e.g.

pipetting system, sample preparation system, etc. offered according to the following terms:

2.4.9.4.1. Service Requirements

2.4.9.4.1.1. 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 2 hours.

2.4.9.4.1.2. Equipment repair service shall be provided during core business hours Monday through Friday 7:00 AM to 4:00 PM. 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.

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

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

2.4.9.4.1.5. 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:

2.4.9.4.1.5.1. Date and time notified

2.4.9.4.1.5.2. Date and time of arrival

2.4.9.4.1.5.3. Serial number, type, and model number of equipment

2.4.9.4.1.5.4. Time spent for repair, and

2.4.9.4.1.5.5. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

2.4.9.5. Upgrades – The Contractor shall provide upgrades to both the equipment hardware and software 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 awarded contract; however, it does refer to significant changes in the hardware operational capability.

2.4.9.6. Ancillary support equipment – The Contractor shall provide, install and maintain through the life of the awarded contract, 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, 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, etc.

2.4.9.7. Commercial offerings. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., computer disc containing their procedure manual in

CLSI format or an online procedure manual in the instrument software.

2.4.9.8. 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 al and applicable state 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 Occupational

Safety and Health Administration (OSHA) and Environmental Protection Agency

(EPA), the analytical process used to determine the hazardous nature and characteristics of waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with the testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to decide if the waste is a hazardous waste or otherwise regulated.

2.4.9.8.1. The determination and description shall address the following:

2.4.9.8.1.1. Waste toxicity (Reference 40 CFR 261.11 and 40 CFR 261.24)

2.4.9.8.1.2. Waste ignitability (Reference 40 CFR 261.21)

2.4.9.8.1.3. Waste corrosivity (Reference 40 CFR 261.22)

2.4.9.8.1.4. Waste reactivity (Reference 40 CFR 261.23)

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

CFR 261.31)

2.4.9.8.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

2.4.9.8.1.7. Solid waste (Reference 40 CFR 261.2)

2.4.9.8.1.8. Exclusions (Reference 40 CFR 261.4)

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

Recovery Act (RCRA) requirements for training as applicable to devices.

2.4.9.8.3. The contractor shall provide a description of all wastes the process of equipment may discharge so that the facility can determine whether the discharge meets local, federal, and state discharge requirements. At a minimum, the characteristics of ignitability, corrosiveness, 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 CRF 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 (e.g. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

2.4.9.8.3.1. Barium (Total)

2.4.9.8.3.2. Cadmium (Total)

2.4.9.8.3.3. Chromium (Total)

2.4.9.8.3.4. Copper (Total)

2.4.9.8.3.5. Cyanide (Total)

2.4.9.8.3.6. Lead (Total)

2.4.9.8.3.7. Mercury (Total)

2.4.9.8.3.8. Nickel (Total)

2.4.9.8.3.9. Silver (Total)

2.4.9.8.3.10. Zinc (Total)

2.4.9.8.3.11. Arsenic (Total)

2.4.9.8.3.12. Selenium (Total)

2.4.9.8.3.13. Tin (Total)

2.4.9.8.3.14. pH

2.4.9.8.3.15. Flash point (to higher than 200°F)

2.4.9.8.3.16. BOD; biochemical oxygen demand

2.4.9.8.4. The documentation the contractor provides will be used to work with the

VA Medical Center and the public and/or private organization (e.g.

MMSD) to determine whether the waste from each device can legally be disposed of via the sewerage system.

2.4.10. Interface Requirements

2.4.10.1. 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.

2.4.10.2. The Contractor shall provide 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.

2.4.10.3. 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.

2.4.10.4. 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.

2.4.10.5. 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 computer hospital information system.

2.4.11. Implementation/transition timeframe –

2.4.11.1. The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the contract. 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 120-day timeframe if the extension is through no fault to the Contractor and is a result of delays due to the Government.

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

2.4.11.3. Contractor shall provide with its quotation an implementation plan for installation of their equipment. Contractor’s submitted plan shall not exceed 120 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations. Failure of the

Contractor to conform to the transition period shall be considered as sufficient cause to terminate the awarded contract for cause under the Termination for Cause clause of the awarded contract.

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

2.4.12. 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, awarded contract, or purchase order is accepted by the Government. This also includes replacements, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in the awarded contract at an effectiveness level of 90% or more.

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

2.4.12.2. If the equipment fails to meet the standard of performance after 120 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the awarded contract in accordance with the provisions of

FAR 52.212-4 entitled “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 120-day acceptance period.)

2.4.12.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the

Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

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

2.4.12.5. The Government will maintain daily records to satisfy the requirements of the

Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.4.12.6. During the term of the awarded contract, 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 Contracting Officer Representative (COR) 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. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

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

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

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

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

2.4.16. Prior to termination or completion of the awarded contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing the awarded contract 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 awarded contract.

2.4.17. 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 awarded contract or (ii) disposal or return of the IT equipment by the

Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the awarded contract or disposal or return of the IT equipment, whichever is earlier.

2.4.18. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

2.4.18.1. Contractor must accept the system without the drive;

2.4.18.2. VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

2.4.18.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

2.4.19. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

2.4.19.1. The Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2.4.19.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the awarded contract.

2.4.19.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

INFORMATION SECURITY LANGUAGE

1. GENERAL. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data –

General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with

Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector

General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity

Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements.