S02 - SF30 SOLICITATION 36C24625Q0977.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

558-25-1-122-0030

36C24625Q0977 07-31-2025

Daniel Spaulding 757-722-9961 x17592 08-08-2025

05:30PM EDT

daniel.spaulding@va.gov Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

X

334510

1250 Employees

N/A

X

Durham VA Medical Center 508 Fulton Street Attn: Kiristin Singleton Durham NC 27705

Network Contracting Office 6

Financial Services Center

PO BOX 149971

Austin TX 78714-9971

512-460-5049 512-460-5221

X

See CONTINUATION Page

Title: Hemodialysis Machines for the Durham VA Medical Center located in Durham, NC

See Section E.1 Instructions to Offerors and Evaluation Criteria

All delivery, installation and training to be completed within 90 days ARO.

See CONTINUATION Page

558-3650160-122-820100-3131 010044175

X X

Daniel Spaulding Contracting Officer, NCO 6

36C24625Q0977

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 SALIENT CHARACTERISTICS

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

B.5 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.225-5 TRADE AGREEMENTS (NOV 2023)

C.2 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

C.3 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.6 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 25

C.9 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 SPECIFIC INSTRUCTIONS TO OFFERORS AND EVALUATION CRITERIA

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C246 Daniel Spaulding daniel.spaulding@va.gov

Department of Veterans Affairs

Network Contracting Office 6

100 Emancipation Drive

Hampton VA 23667

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon complete delivery, installation and training

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

mailto:daniel.spaulding@va.gov https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

HEMODIALYSIS MACHINES

Location: Durham VA Medical Center (Durham, NC)

1. Background

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) requires hemodialysis machines (also referred to as hemodialysis systems or dialysis machines) for the Durham, VA Medical Center, located at 508 Fulton Street, Durham, NC 27705 that provide dialysis to Veterans. This requirement includes the hemodialysis machines, the dialysis machine software, and all maintenance services (including corrective and preventive maintenance). The hemodialysis machine is one of the most important products in the treatment of chronic renal patients. The hemodialysis machine controls key functions during treatment by pumping blood from the patient’s body through the blood lines to the dialyzer (artificial kidney or filter). In the dialyzer, a fluid known as dialysate transports the toxins and excess water filtered from the blood away from the body. The fluid is introduced against the flow of blood through a separate circuit that is also controlled by the hemodialysis machine. In addition, the machine injects drugs (such as Heparin) that prevent coagulation. Hemodialysis machines must have automatic monitoring and control functions to ensure safe and efficient treatment.

2. Scope

This Statement of Work (SOW) identifies the requirements for the hemodialysis machines and its dialysis machine software. All equipment, software, and services shall be in accordance with the specifications defined or identified in this SOW. A summary of the required equipment, software, services, and documentation is as follows:

2.1 Delivery, installation, activation, calibration, and baseline testing with certification that the dialysis machines are safe for patient treatment.

2.2 Initial on-site and refresher user training on machine operation

2.3 Factory-level dialysis machine service training for VA biomedical engineers/ technicians

2.4 A one-year warranty for each dialysis machine

2.6 Turnkey dialysis machine software solution including: delivery, installation, testing, configuration, integration, documentation, full functionality, and interface with the dialysis machine. The software must have the ability to interface with VA’s electronic medical record (referred to as the Computerized Patient Record System (CPRS) and National Renal Administrations Association (NRAA) certified electronic medical record (EMR) systems using HL-7 syntax. The solution must include: all hardware and software, annual corporate site licenses (if applicable); software updates needed for full compatibility with the dialysis machines, CPRS, and NRAA certified EMRs; help desk support and troubleshooting preventative maintenance, documentation; and training.

Note: VA will be establishing a separate contract for procurement of a NRAA certified EMR system

2.7 Documentation includes: Food and Drug Administration (FDA) 510(k) certification, test reports, dialysis machine and software user guide dialysis machine complete factory-level service manual; software installation guide troubleshooting procedures; and service reports.

3. Applicable Documents

The Contractor shall comply with the following references for conduct of this requirement.

3.1 VA Handbook 6500.6, Contract Security, March 10, 2010; Refer to http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=471&FType=2

3.2 VA Directive 6550, Pre-Procurement Assessment for Medical Devices, September 5, 2007; Refer to http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=790&FType=2

3.3 US Food and Drug Administration (FDA); Medical Devices; Products and

Medical Procedures and Medical Device Safety; Refer to http://www.fda.gov/MedicalDevices/default.htm

3.4 American Association of Medical Instrumentation (AAMI) Standards; Dialysis Collection; Refer to http://www.aami.org/publications/standards/

3.5 Centers for Medicare and Medicaid (CMS) guidelines-CMS End Stage Renal Disease (ESRD) Conditions for Coverage https://www.cms.gov/Regulations-and- Guidance/Legislation/CFCsAndCoPs/downloads/esrdfinalrule0415.pdf

3.6 HL7 – Health Level 7 Standards; Refer to http://www.hl7.org/

3.7 Computerized Patient Record System (CPRS) compatibility; Release date 2012

3.8 NRAA-certified EMRs; Refer to http://www.renalexchange.com/nraa-hie-for-crownweb/

4. Tasks and Requirements http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=471&FType=2 http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=790&FType=2 http://www.fda.gov/MedicalDevices/default.htm http://www.aami.org/publications/standards/ https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/downloads/esrdfinalrule0415.pdf https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/downloads/esrdfinalrule0415.pdf http://www.hl7.org/ http://www.renalexchange.com/nraa-hie-for-crownweb/

The Contractor shall deliver, install, activate, calibrate, test, and fully demonstrate the hemodialysis machines at The Durham, VA Medical Center, located at 508 Fulton Street, Durham, NC 27705.

4.1 Program and Quality Control

The Contractor shall ensure that all requirements in this SOW are met and shall provide quality control measures to ensure continued technical performance and schedule. The Contractor shall track warranty start dates, expiration dates, maintenance and service calls, FDA recalls, and manufacturer recalls. The Contractor shall track and report VA sales (e.g., quantity, unit model/serial numbers, locations, maintenance coverage dates, software sales and version per installation, software updates, and related data).

The Contractor shall comply with all Government information security requirements and Health Insurance Portability and Accountability Act (HIPAA) regulations. In accordance with VA Handbook 6500.6, the Certification and Accreditation (C&A) requirements do not apply and a security accreditation package is not required for this requirement.

4.2 Supplies, Parts, and Materials

The Contractor shall procure and provide all materials, parts, hardware, tools, and supplies needed to perform the tasks and requirements identified in this SOW.

4.3 Operating Hours, Capacity, and Status Definitions

The Contractor shall recognize and comply with the following operating conditions and definitions.

4.3.1 Delivery and Service Coordination

The Contractor shall coordinate with the Contracting Officer’s Representative (COR) to identify a time when the dialysis machine(s) are to be delivered, installed, or receive warranty maintenance that minimizes disruption to patient treatment.

4.4 Hemodialysis Machines – Delivery, Installation, and Testing

The Contractor shall deliver, install, test, calibrate, and certify functionality of the hemodialysis machines. The Contractor shall ensure that representatives performing installation, testing, and maintenance are factory-trained and certified experts in the hemodialysis machines. The Contractor shall not delegate such tasks to a representative that is not a certified expert in hemodialysis machine operation, use, testing, calibration, and maintenance. The Contractor shall deliver the operator’s manual, user’s guide, and related procedures with the hemodialysis machines.

4.4.1 Hemodialysis Machine Connections and Compatibility

The Contractor is only responsible for installation of the Hemodialysis Machines per the manufacturers approved procedures. Any accessories required to connect AK 98 to the existing facility infrastructure is the responsibility of the purchaser.

4.4.2 Installation

The Contractor factory-trained and certified expert(s) shall install and conduct baseline testing of the dialysis machines and associated machine components on the date specified in the delivery order.

4.4.3 Hemodialysis Machine Baseline Testing

The Contractor shall ensure coordination with the COR to establish a mutual date (no later than seven (7) business days after delivery) to start the process of baseline testing. The Contractor shall activate the dialysis machines including set-up, testing, and complete calibration of each machine according to manufacturer’s specifications and installation requirements. The Contractor shall conduct and complete baseline testing of the dialysis machines and provide the VA test results for each dialysis machine at the completion of baseline testing. The Contractor shall ensure and certify that the hemodialysis machines are safe for patient treatments and that the machines meet the manufacturer’s specifications at the end of baseline testing.

4.4.4 Government Acceptance Testing

The dialysis center staff will conduct testing and evaluation of the dialysis machines prior to equipment acceptance. The Contractor shall assist and observe as requested by the COR.

The Contractor shall resolve any issues discovered during acceptance testing. The Government will complete acceptance testing of the hemodialysis machines no later than thirty (30) calendar days from completion of Contractor baseline testing. In the event that an anomaly is discovered, the equipment is not functioning, or is in any way unsafe to treat patients; acceptance testing will be extended. Acceptance by the Government is required for payment. The acceptance of hemodialysis machines will include the following:

a. Contractor completion of baseline testing and certification that the machines meet the manufacturer’s specifications, all FDA and regulatory requirements, and are safe to use to treat patients;

b. Hemodialysis machines operate according to the manufacturer specifications and AAMI guidelines;

c. Hemodialysis machines are certified and verified safe for patient use/treatment;

d. Hemodialysis machine user’s manuals and guides are shared

e. Contractor’s user training has been successfully completed.

4.5 Hemodialysis Machine - Warranty

The Contractor shall provide the following warranty for dialysis machines.

4.5.1 Warranty Services

Hemodialysis machines purchased under this contract shall be brand new, free from defects in materials and workmanship, and shall include a minimum one-year (1) warranty. The warranty period will be specific to each machine and shall begin upon VA site’s acceptance of each machine. The warranty shall include product support for the purchased machines to ensure the system is operating at optimum performance levels, is in conformance with product specifications, and is free from all defects. The warranty shall include support, all parts, supplies, materials, tools, and labor at no additional cost to the VA. Correction of issues shall be performed by the Contractor’s factory trained and certified representative.

The Contractor shall provide a warranty on all repairs and services and certify that the system is fully operational after such repair or service during the warranty period. The Contractor shall coordinate with each VA site to schedule service during the warranty period.

4.5.2 Warranty Service Reporting

The Contractor shall prepare a service report and provide it to the COR at the conclusion of the warranty service. The Contractor shall ensure all services performed are fully documented (service reports) and include the following information:

a. Model and serial number of equipment serviced.

b. Date and time called, time of arrival, point of contact, and reason for call.

c. Name of the technician.

d. Description of all work performed, and identification of all parts replaced including part numbers and serial numbers.

e. Written procedures followed and evidence that equipment has been inspected, calibrated, and retested/certified according to those procedures.

f. Provision and placement of labels on the part and machine to indicate that the item/machine was serviced.

4.6 Software – Installation, Test, and Demonstration

The Contractor shall provide a turn-key dialysis machine software solution including installation, integration, interface, configuration, and full functional demonstration of the software with the hemodialysis machines. The software must have the capability of interfacing with CPRS and NRAA certified EMR’s using HL-7 syntax. The Contractor shall ensure coordination with the COR and DCMD to establish a mutual date and time for installation and demonstration to enable VA personnel to be present.

The Contractor shall provide all hardware, cables, software, and equipment needed. The Contractor shall ensure the software performs to manufacturer’s specifications and that the latest software configurations are identified, installed, and recorded. The Contractor shall provide test reports and certify completion of testing including certification that the software meets all requirements and documentation of the software version(s) installed.

4.6.1 Software Acceptance Testing

The DCMD and dialysis center staff will conduct testing and evaluation of the software prior to acceptance. The Contractor shall assist and observe as requested by the COR. The Contractor shall resolve any issues discovered during acceptance testing. The Government will complete acceptance testing of the software no later than 10 calendar days from the completion of Contractor’s installation and demonstration.

The acceptance of software will include the following:

a. Contractor completion of software testing and certification that the software is operating to specifications;

b. Contractor completion of full functionality software demonstration with the dialysis machines and interface with CPRS and NRAA certified EMRs;

c. Government acceptance testing successfully completed and/or all issues have been resolved; and

d. User training by the Contractor has been successfully completed and dialysis staff trained to independently use, chart, and identify, troubleshoot, and report software problems.

4.7 Training Requirements

The Contractor shall provide all training for the hemodialysis machines and software.

4.7.1 Hemodialysis Machine User Training

Once the Contractor has completed baseline testing and issued written verification of dialysis machine functionality and safety to treat patients, the Contractor shall provide on-site training on the operation and use of the hemodialysis machines to VA dialysis staff. The Contractor shall conduct hemodialysis machine training no later than five (5) calendar days after baseline testing is completed. Training shall be a minimum of two weeks (80 hours).

The Contractor shall conduct additional operator training on an as-needed basis.

4.7.2 Hemodialysis Machine Refresher Training

The Contractor shall provide on-site (or alternate delivery) dialysis machine operator refresher training. The Contractor shall coordinate the refresher training with the COR for each site.

4.7.3 Hemodialysis Machine Factory Service Training

The Contractor shall provide complete factory service training on the hemodialysis machines for up to five VA biomedical engineers and/or technicians from each site on an as-needed basis and if requested by the VA site. The Contactor shall host the factory training at the manufacturer’s plant or training location/facility. The Contractor shall provide the complete hemodialysis machine service manual(s) and any other factory-level service/repair documentation for all sites that have factory-level trained personnel.

4.7.4 Software Initial Training

The Contractor shall provide software user and technical training as part of the delivery and installation on the date coordinated with the COR and dialysis center staff. The Contractor training shall include interface, charting, reporting application and use, demonstration of all user functions, configuration, and interface with the machines, CPRS, and NRAA certified EMRs. The Contractor shall conduct the training at each site for a minimum of five (5) VA dialysis staff. The Contractor shall conduct training on basic troubleshooting, interface, and user problems to include problem indicators, warnings and alarms.

5. Hemodialysis Machine and Software and Technical Requirements

The Contractor shall provide hemodialysis machine and software that meets the respective technical requirements (TRs). The Contractor shall ensure that equipment and services provided meet manufacturer’s specifications, FDA 510 (k) compliance requirements, AAMI and Centers for Medicare and Medicaid (CMS) guidelines, and applicable documents referenced in this SOW respectively.

5.1 Dialysis Machine Technical Requirements (TR)

All dialysis machines shall meet the following TRs:

a. Shall be a self-contained, microprocessor-controlled device capable of providing hemodialysis, hemofiltration, and ultrafiltration (UF) therapies.

b. Shall consist of the hemodialysis machine with a blood tubing set designed for the dialysis machine, a dialyzer, a heparin-filled syringe, and appropriate dialysate concentrates.

c. Shall have safety design feature of maximal ultrafiltration precision and if possible include demonstrated customer satisfaction with achievement in-the-field of published rates.

d. Shall have built-in arterial and venous pressure monitoring system for monitoring of venous pressure. Shall be capable of triggering an alarm when the patient’s venous pressure falls below the alarm threshold set by the operator. Shall have safe design that automatically performs inviolable machine safety checks before each treatment, as well as options for battery back–up and in-line endotoxin filter.

e. Shall offer intelligent design features including noise mitigation, option for online kinetic modeling via integrated or alternative method, dialysate conservation options, tolerance of wide range of dialysis water temperatures.

f. Shall allow for online mixing of dry bicarbonate and/or use of premixed bicarbonate solution.

g. Shall have safe design features including option to use transducer protector-free bloodlines and lines minimizing extracorporeal blood volume.

h. Shall meet local and AAMI standards for water quality.

i. Shall have a color touch screen that shows:

1. Parameters and commands selected by the operator;

2. Alarm messages;

3. Operator messages;

4. Status icons and pictograms; and

5. Navigation keys to access different views on touch screen.

j. Shall have timers for auto start to allow for integrated heat disinfection with central reverse osmosis (RO) system.

k. Shall allow for UF and sodium profiling.

l. Shall have sodium bicarbonate cartridge and/or bicarbonate line/connector that attaches to a central bicarbonate supply or premix bicarbonate container.

m. Shall have U9000 holder.

n. Shall have a back-up battery.

o. Shall include ¾ inch female garden hose connector

Shall contain the following components:

1. Main control panel

2. Blood pump control panel

3. Blood pump cover with cover latch

4. Blood pump

5. Level detector

6. Patient sensor

7. Arterial line clip

8. Venous line clip

9. Acid/Acetate line

10. Bicarbonate line

11. Disinfectant line

12. Locking

13. Heparin syringe holder

14. Heparin control panel

15. Heparin syringe plunger clamp

16. Blood leak detector

17. Blood pressure cuff holder

18. Main power switch

19. Solution bag hooks

20. IV pole

21. Status light

22. Computer interface panel

23. Blood pressure tubing connector

24. Air vents

25. Wand holder

26. Power cord

27. Inlet water hose

28. Drain hose

29. Dialysate line from and to dialyzer

42. Dialyzer holder

5.2 Software Technical Requirements

The Contractor shall deliver and install a turnkey hemodialysis machine software solution that meets the following TRs:

a. Shall include all required software and hardware necessary for optimal functioning and interface with the hemodialysis machines;

b. Shall have capability of interfacing with and exporting data to CPRS and NRAA certified EMRs using HL-7 syntax;

c. Shall have capability of collecting treatment data from the dialysis machine using standard ethernet (CAT5);

d. Shall have capability of collecting data from the keyboard;

e. Shall have capability of storage of data in a secure database;

f. Shall have capability of displaying treatment data including pre-assessment, flow sheet, and post-assessment;

g. Shall allow users to print reports of treatment data;

h. Shall have capability of documenting dialysis machine disinfection and rinses;

i. Shall have capability of operating in stand-alone or client-serve modes;

j. Shall have capability of acquiring, processing, and supplying data required when running a dialysis treatment;

k. Shall have capability of inserting, modifying, acquiring, and displaying in text and graphical form data about dialysis prescription, ongoing and performed dialysis treatments, and patient personal data;

l. Shall comply with all Government information security requirements and HIPAA regulations. Refer to the VA Contract Security Requirements in the contract clausesShall allow for download of patient prescriptions to the dialysis machine;

and

m. Shall have an on-screen charting capability.

6. Government Evaluation and Monitoring The DCMD will evaluate and monitor hemodialysis machine and software performance and conduct testing including results during and after patient treatments. The Government will verify that each dialysis machine meets clinical requirements and conduct follow-up bacteriologic testing according to AAMI guidelines. The Government will inform the Contractor of any issues discovered for remedy by the Contractor. If the issue is deemed to be an emergency by the Government and patient safety is compromised, the Contractor shall use emergency response times defined in this SOW. The DCMD will assess the following throughout the life of the hemodialysis machines and software:

a. Hemodialysis machines continue to operate according to manufacturer’s specifications and AAMI guidelines;

b. Machines are safe for patient treatment (e.g., product recalls, FDA recalls, et al);

c. Machines continue to meet required operating capacity.

d. Software remains compatible with the machines.

e. Software continues capability of interfacing with CPRS and NRAA certified EMRs using

HL7 syntax.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

1. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

2. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

3. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security and Preparedness.

B.3 SALIENT CHARACTERISTICS

SALIENT CHARACTERISTICS of the Brand Name Item: Please note, all offered products must be technically equivalent to or exceed the Brand Name product listed. See below.

The quoted products shall meet or exceed the below listed characteristics of the Brand Name item, AK98 Hemodialysis Machine (955607), manufactured by Vantive US Healthcare LLC:

Provide all therapy options including conventional 3x/week, short daily, or nocturnal.

Capable of sodium profiling

Capable of bicarbonate profiling.

Ceramic concentrate pumps

Electromagnetic flow meters.

At least 30 minutes of battery backup.

Direct push-pull capability between the machine and the EMR.

Capture data every 60 seconds.

Receive up to 50 treatment parameters.

Include integrated formula for automatic calculations.

Standby mode that does not use any concentrate.

Does not require a pH probe for flow rate calculations.

Machine can self-clear nuisance pressure alarms.

Automatic disinfection routines.

Heat centric disinfection to take no longer than 60 minutes.

Short heat centric disinfection to take no longer than 30 minutes.

Bleach disinfection to take no longer than 60 minutes.

Heat disinfection to take no longer than 45 minutes.

Drain phase included in heat centric, bleach, and heat disinfection programs.

Can monitor Kt/V in each treatment simultaneously.

Treatments can be done at a flow rate of up to 800 mL/min.

Treatments can be done at a blood flow rate of at least 20 mL/min.

Arterial and Venous pressures monitored and visible on screen.

The quoted products shall meet or exceed the below listed characteristics of the Brand Name item, Accessory shelf extension kits (956016), manufactured by Vantive US Healthcare LLC:

Device must be able to attach on either side of the device.

Device to be no greater than 8 inches wide.

Device to be no greater than 15 inches deep.

Device able to support 70 lbs. or greater.

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QTY UNIT UNIT PRICE AMOUNT

21.00 EA __________________ __________________

Hemodialysis Machines. See salient characteristics.

Contract Period: Base POP Begin: 08-15-2025 POP End: 11-15-2025 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 0

NATIONAL STOCK NUMBER: 0

LOCAL STOCK NUMBER: 0

1.00 LT __________________ __________________

Installation. The Contractor shall deliver, install, activate, calibrate, test, and fully demonstrate the hemodialysis machines delivered to the Durham, VA Medical Center, located at 508 Fulton Street, Durham, NC 27705.

Contract Period: Base POP Begin: 08-15-2025 POP End: 11-15-2025 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 0

NATIONAL STOCK NUMBER: 0

LOCAL STOCK NUMBER: 0

Installation and validation shall be included in the procurement cost and shall include but not limited to:

Assembly of devices and validation.

All materials required to assembly dialysis units and accessory shelf kits shall be provided by the contractor.

1.00 LT __________________ __________________

Training. Training shall include: (1.) Initial on-site and refresher user training on machine operation. (2.) Factory-level dialysis machine service training for VA biomedical engineers/ technicians.

Contract Period: Base POP Begin: 08-15-2025 POP End: 11-15-2025 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

MANUFACTURER PART NUMBER (MPN): 0

NATIONAL STOCK NUMBER: 0

LOCAL STOCK NUMBER: 0

GRAND TOTAL __________________

B.5 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001 SHIP TO: VA Durham Medical Center 508 Fulton St Requiring Service // Attn: Kirista Singleton Durham, NC 27705 United States

21.00 90 Days ARO

MARK FOR: Kirista Singleton

(919) 286-0411 ext 7311

KIRISTA.SINGLETON@VA.GOV

FOB: DESTINATION

0002 SHIP TO: VA Durham Medical Center 508 Fulton St Requiring Service // Attn: Kirista Singleton

1.00 90 Days ARO

0003 SHIP TO: VA Durham Medical Center 508 Fulton St Requiring Service // Attn: Kirista Singleton

1.00 90 Days ARO

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.225-5 TRADE AGREEMENTS (NOV 2023)

(a) Definitions. As used in this clause.

"Caribbean Basin country end product"—

(1) Means an article that—

(i)(A) Is wholly the growth, product, or manufacture of a Caribbean Basin country; or

(B) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in a Caribbean Basin country into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed; and

(ii) Is not excluded from duty-free treatment for Caribbean countries under 19 U.S.C.

2703(b).

(A) For this reason, the following articles are not Caribbean Basin country end products:

(1) Tuna, prepared or preserved in any manner in airtight containers;

(2) Petroleum, or any product derived from petroleum;

(3) Watches and watch parts (including cases, bracelets, and straps) of whatever type including, but not limited to, mechanical, quartz digital, or quartz analog, if such watches or watch parts contain any material that is the product of any country to which the Harmonized Tariff Schedule of the United States (HTSUS) column 2 rates of duty apply (i.e., Afghanistan, Cuba, Laos, North Korea, and Vietnam); and

(4) Certain of the following: textiles and apparel articles; footwear, handbags, luggage, flat goods, work gloves, and leather wearing apparel; or handloomed, handmade, and folklore articles;

(B) Access to the HTSUS to determine duty-free status of articles of these types is available at https://www.usitc.gov/tata/hts/index.htm. In particular, see the following:

(1) General Note 3(c), Products Eligible for Special Tariff treatment.

https://www.usitc.gov/tata/hts/index.htm

(2) General Note 17, Products of Countries Designated as Beneficiary Countries under the United States—Caribbean Basin Trade Partnership Act of 2000.

(3) Section XXII, Chapter 98, Subchapter II, Articles Exported and Returned, Advanced or Improved Abroad, U.S. Note 7(b).

(4) Section XXII, Chapter 98, Subchapter XX, Goods Eligible for Special Tariff Benefits under the United States—Caribbean Basin Trade Partnership Act; and

(2) Refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the acquisition, includes services (except transportation services) incidental to the article, provided that the value of those incidental services does not exceed that of the article itself.

"Designated country" means any of the following countries:

(1) A World Trade Organization Government Procurement Agreement (WTO GPA) country (Armenia, Aruba, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea (Republic of), Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Moldova, Montenegro, Netherlands, New Zealand, North Macedonia, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Taiwan (known in the World Trade Organization as "the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu (Chinese Taipei)”), Ukraine, or United Kingdom);

(2) A Free Trade Agreement (FTA) country (Australia, Bahrain, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Korea (Republic of), Mexico, Morocco, Nicaragua, Oman, Panama, Peru, or Singapore);

(3) A least developed country (Afghanistan, Angola, Bangladesh, Benin, Bhutan, Burkina Faso, Burundi, Cambodia, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gambia, Guinea, Guinea-Bissau, Haiti, Kiribati, Laos, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Nepal, Niger, Rwanda, Samoa, Sao Tome and Principe, Senegal, Sierra Leone, Solomon Islands, Somalia, South Sudan, Tanzania, Timor-Leste, Togo, Tuvalu, Uganda, Vanuatu, Yemen, or Zambia); or

(4) A Caribbean Basin country (Antigua and Barbuda, Aruba, Bahamas, Barbados, Belize, Bonaire, British Virgin Islands, Curacao, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, Saba, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Sint Eustatius, Sint Maarten, or Trinidad and Tobago).

"Designated country end product" means a WTO GPA country end product, an FTA country end product, a least developed country end product, or a Caribbean Basin country end product.

"End product" means those articles, materials, and supplies to be acquired under the contract for public use.

"Free Trade Agreement country end product" means an article that—

(1) Is wholly the growth, product, or manufacture of a Free Trade Agreement (FTA) country;

or

(2) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in an FTA country into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product includes services, (except transportation services) incidental to the article, provided that the value of those incidental services does not exceed that of the article itself.

"Least developed country end product" means an article that—

(1) Is wholly the growth, product, or manufacture of a least developed country; or

(2) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in a least developed country into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product, includes services (except transportation services) incidental to the article, provided that the value of those incidental services does not exceed that of the article itself.

"United States" means the 50 States, the District of Columbia, and outlying areas.

"U.S.-made end product" means an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.

"WTO GPA country end product" means an article that—

(1) Is wholly the growth, product, or manufacture of a WTO GPA country; or

(2) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in a WTO GPA country into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product includes services, (except transportation services) incidental to the article, provided that the value of those incidental services does not exceed that of the article itself.

(b) Delivery of end products. The Contracting Officer has determined that the WTO GPA and FTAs apply to this acquisition. Unless otherwise specified, these trade agreements apply to all items in the Schedule. The Contractor shall deliver under this contract only U.S.-made or designated country end products except to the extent that, in its offer, it specified delivery of other end products in the provision entitled "Trade Agreements Certificate."

(End of Clause)

C.2 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

(a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements."

(b) The offeror shall list as other end products those supplies that are not U.S.-made or designated country end products.

Other End Products

Line item No. Country of origin

[List as necessary]

(c) The Government will evaluate offers in accordance with the policies and procedures of Part 25 of the Federal Acquisition Regulation. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for those products are insufficient to fulfill the requirements of this solicitation.

(End of Provision)

C.3 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION

(JAN 1997)

(a) The Contractor shall, at its own expense, provide and maintain during the entire performance of this contract, at least the kinds and minimum amounts of insurance required in the Schedule or elsewhere in the contract.

(b) Before commencing work under this contract, the Contractor shall notify the Contracting Officer in writing that the required insurance has been obtained. The policies evidencing required insurance shall contain an endorsement to the effect that any cancellation or any material change adversely affecting the Government's interest shall not be effective—

(1) For such period as the laws of the State in which this contract is to be performed prescribe; or

(2) Until 30 days after the insurer or the Contractor gives written notice to the Contracting Officer, whichever period is longer.

(c) The Contractor shall insert the substance of this clause, including this paragraph (c), in subcontracts under this contract that require work on a Government installation and shall require subcontractors to provide and maintain the insurance required in the Schedule or elsewhere in the contract. The Contractor shall maintain a copy of all subcontractors' proofs of required insurance, and shall make copies available to the Contracting Officer upon request.

(End of Clause)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

(End of Clause)

C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.6 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

(a) The contractor shall comply with Executive Order 13899, Combating Anti-Semitism, pursuant to Title VI of the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d et seq.

(b) The contractor shall timely disclose, in writing, to the Contracting Officer, whenever, in connection with the award, performance, or closeout of this contract or any subcontract thereunder, the Contractor has credible evidence that a principal, employee, agent, or subcontractor of the Contractor has committed a violation under Executive Order 13899, Combatting Anti-Semitism pursuant to the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d et seq.

(c) The contractor shall include the terms and conditions of this clause in every subcontract or purchase order so that these terms will be binding on every subcontractor or vendor.

(End of Clause)

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts…