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Department of Veterans Affairs

National Dialysis Equipment Procurement

Hemodialysis Systems and Associated Maintenance Services

STATEMENT OF WORK

DEPARTMENT OF VETERANS AFFAIRS

HEMODIALYSIS SYSTEMS AND ASSOCIATED MAINTENANCE SERVICES

STATEMENT OF WORK

1. Introduction

The Department of Veterans Affairs (VA) is seeking a vendor that can provide hemodialysis systems (also referred to as dialysis machines) and perform the associated hemodialysis system maintenance requirements; including corrective and preventive maintenance services, to any VA site in the United States that provides dialysis treatment to Veterans.

The hemodialysis system is one of the most important products in the treatment of chronic renal patients and, in hemodialysis, it takes over a number of key functions – it pumps blood from the patient’s body through the blood lines to the dialyzer (artificial kidney or filter). There, 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 system. In addition, the device injects drugs (such as Heparin) that restrain coagulation. The system has a number of automatic monitoring and control functions that ensure a safe and efficient dialysis treatment for patients.

Hemodialysis systems also continuously collect a variety of data during treatment including arterial and venous pressure, the rotating speed of the blood pump and the temperature as well as the composition of the dialysate. In addition, the hemodialysis system controls the amount of fluid removed from the body. A clamp prevents air bubbles from entering a patient’s body. Should one of the values exceed or fall below established levels, the hemodialysis system reacts immediately and halts or alters the treatment accordingly until the value returns to the approved range – the patient’s safety is the most important part of dialysis.

2. Purpose and Objectives

Purpose: The purpose of this Statement of Work (SOW) is to establish a contract between the Department of Veterans Affairs and a vendor that is capable of furnishing hemodialysis systems and performing all required corrective and preventative maintenance services to any VA site in the United States according to the technical specifications defined in this SOW.

3.0 Performance Details

3.1 This is a competitive acquisition for a single-award of a Requirements Firm-Fixed-Price Commercial Contract.

3.2 Period of Performance

The period of performance will consist of a 12-month base period from date of contract award with four one-year option periods that may be exercised by the Government.

3.3. Place of Performance

The contractor shall provide hemodialysis systems and perform associated corrective and preventive maintenance services directly to VA facilities located throughout the United States, Puerto Rico, and the Philippines.

3.4 Estimated Quantities

The number of hemodialysis systems and maintenance delivery orders procured by the VA for this requirement will be variable and at the discretion of the VA.

3.5 Delivery Requirements

The contractor shall deliver and install the hemodialysis systems on a date and location specified by the government. The date for delivery and machine installation may be different and will be determined by the government.

3.6 Hours of Operation

VA dialysis centers will operate either two or three patient shifts per day, six days a week. VA dialysis centers operating two shifts per day will operate from early morning (5AM) until approximately 6 PM, Monday-Saturday. VA dialysis centers operating three shifts per day will operate from early morning (5AM) until approximately 9 PM, Monday-Saturday. The dialysis center staff will coordinate the time of service with the contractor, and the contractor will be able to provide the required services at the times when the hemodialysis systems are not being used for treatment. The dialysis centers will operate on all federal holidays. The ten (10) holidays observed by the Federal Government are follows: New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas.

4.0 Tasks and Sub-Tasks

The contractor shall provide the products and perform the tasks as outlined in this section. All required coverage will be procured via delivery order issuance and coverage will commence in accordance with the individual delivery orders. Each delivery order will contain the specific contracting terms and conditions. Contracting terms shall include: item quantities, and all necessary delivery and payment details.

The contractor shall provide the required hemodialysis systems and perform all corrective and preventive maintenance services according to the technical specifications defined below.

4.1 Hemodialysis Systems: The contractor must include all technical requirements detailed in this SOW including but not limited to the following: hemodialysis system that meets the technical requirements defined in this SOW, all regulatory documentation, hemodialysis system standard operating procedures (paper and electronic format), complete service manual, two year all inclusive warranty, hemodialysis system space and design specifications (paper and electronic format), on-site training performed by the vendor for all clinical dialysis staff, written training and quality improvement guide, vendor installation of the hemodialysis systems and activation of the hemodialysis systems, vendor testing of the system to ensure the system operates according to all Association for the Advancement of Medical Instrumentation (AAMI) and manufacturer specifications, provision of local experts to correct equipment issues, provision of national experts to correct equipment issues when requested by the VA, parts and supplies needed for system installation and testing, vendor travel costs to VA sites for initial installation and subsequent training, informatics capability requirements defined in this solicitation including ability to allow for chair-side charting, HL7 and CP Hemo compatibility, and inclusion of a keyboard on the hemodialysis system for charting.

4.2 Annual All-inclusive Maintenance Contract per Dialysis Machine: The contractor shall provide: vendor on-site performance of all required corrective and preventive maintenance services including emergency services and non-emergency maintenance services, parts, labor, supply, and travel costs associated with performance of required maintenance. The contractor shall identify all required preventive maintenance services for each hemodialysis system, recommended frequency of performance, and the required parts and supplies. The cost of all equipment, parts, labor, and travel should be included in the annual preventive maintenance contract cost and may not be billed separately.

4.3 All parts and supplies required to performance maintenance services

4.4 Time and materials for all on-site services

4.5 Hemodialysis System Installation, Testing, Acceptance, and Payment: Installation must be performed by a designated expert from the vendor’s company. The travel costs incurred by the vendor associated with the initial installation and subsequent travel for system activation, testing, and training should be included in the vendor’s quote and may not be billed separately. Installation, testing, acceptance of the hemodialysis systems and government payment for the hemodialysis systems will adhere to the following process:

1. Delivery: The vendor will deliver the requested number of hemodialysis systems to the specified VA site at a date identified by the government.

2. Vendor Installation and Testing: The government will notify the vendor when the government is prepared to initiate installation and testing of the hemodialysis systems. The vendor’s designated manufacturer trained installation team will travel to the site designated by the VA within 5 business days of notification and complete installation of all hemodialysis systems on a date specified by the VA. Upon installation, the system shall be kept “dry” and shall not been turned on (activated) until determined by the government. Once determined by the government, the vendor shall activate the hemodialysis systems, set-up, and complete calibration of each system according to manufacturer specifications. The vendor shall conduct baseline testing of the hemodialysis systems and send baseline testing on bacterial cultures and endotoxins to the designated laboratory for analysis. If the testing sample results meet manufacturer and AAMI requirements, the vendor must provide the VA with written documentation (electronic and in paper form) verifying that the system operates according to manufacturer and AAMI specifications. The vendor will be required to provide the government with a FDA 510K certificate for each dialysis machine confirming hemodialysis system functionality.

3. VA Testing: Once the vendor has provided written verification of hemodialysis system functionality, the VA will have a minimum of 30 days to complete internal testing of the hemodialysis systems prior to VA acceptance and payment for the hemodialysis systems. This testing will include testing during patient treatments to ensure each hemodialysis system meets clinical requirements as well as follow up bacteriologic testing according to AAMI guidelines. This testing period may be extended beyond 30 days at the VA’s discretion if the VA dialysis center medical director determines additional time is needed to complete testing.

4. Training: Once the vendor has completed baseline testing and issued the written verification of hemodialysis system functionality, the vendor shall provide on-site training to VA dialysis center staff on hemodialysis system operation and maintenance within 5 business days of installing the hemodialysis systems. The vendor will be required to provide comprehensive user training with staff on the machine. Training must be performed during periods prior to patient treatment and during actual patient treatments. On-site training at the VA dialysis center will be a minimum of two weeks. Complete factory service training shall be provided for two VA-employed biomedical engineering technicians. The vendor will provide annual follow-up/refresher training to dialysis center staff that is a minimum of 5 days. The VA may request additional training sessions from the vendor in the event new staff are hired

5. Acceptance and Payment: A decision regarding VA acceptance of the hemodialysis systems will be made by the dialysis center medical director. Government payment for the hemodialysis systems will not occur until all vendor and VA testing is complete, the VA dialysis center medical director has certified that the hemodialysis systems operate according to manufacturer specifications, AAMI guidelines, are safe to use in the treatment of patients, and the hemodialysis systems have been verified to operate according to manufacturer specifications during actual patient treatments. The estimated time period between the vendor’s initial delivery of the hemodialysis systems and the government’s acceptance of the hemodialysis systems will be variable and will be dependent upon the hemodialysis system testing results.

5.0 Equipment Defects and Failure: The below clauses set forth the process, requirements, and vendor responsibilities related to equipment defects and failures.

1. Hemodialysis System Failure of Vendor Baseline Testing: If the VA dialysis center medical director concludes that the results of the vendor baseline testing do not meet AAMI standards, manufacturer specifications, or the hemodialysis systems are not safe to use in the treatment of patients, the vendor will have 10 business days from date of notification from the VA to correct all identified equipment defects to the satisfaction of the dialysis center medical director. Correction of the issue by a vendor’s local personnel may not be accepted by the government. If requested by the government, the vendor will be required to identify an expert from their national office to travel to the designated VA site at no cost to the government to correct the equipment issue/s.

If the vendor is unable to correct the issue to the satisfaction of the dialysis center medical director within 10 business days of written notification from the government, the government will maintain the option of returning all the hemodialysis systems and obtaining a full refund from the vendor for the cost of all hemodialysis machines and supplies. The vendor will also be required to arrange and pay for the cost to return all defective hemodialysis systems from the government location to a location specified by the vendor.

The government will also maintain the option of requesting that the vendor replace all hemodialysis systems. If the government requests a replacement, the vendor will be required to immediately replace all hemodialysis systems and associated parts and supplies at no cost to the government. The vendor will also be required to arrange and pay for the cost to return all defective hemodialysis systems from the government location to a location specified by the vendor. Replacement of all of the hemodialysis systems must occur within 10 business days after the 10 business days allowed for the vendor to correct the issue has elapsed. The vendor will be liable to the government for each day of dialysis center non-operation resulting from malfunction of the hemodialysis systems at a cost of $5,500 per day of non-operation of a 12 station facility, $6,600 per day for non-operation of a 16 station facility, $7,600 for non-operation of a 20 station facility, $8,600 per day for non-operation of a 24 station facility, $10,000 per day for non-operation of a 28 station facility, $11,000 per day for non-operation of a 32 station facility, and $12,000 per day for non-operation of a 36 station facility. The vendor will also be liable for any construction costs associated with replacement of the hemodialysis systems.

2. Hemodialysis System Failure of VA Internal Testing: If the VA dialysis center dialysis center medical director determines after internal testing that the hemodialysis systems do not operate according to manufacturer specifications, do not meet AAMI standards, or are not safe to use in the treatment of patients; the VA will notify the vendor of these findings. The vendor will have 5 business days from date of VA notification to correct all issues to the satisfaction of the dialysis center medical director. Correction of the issue by a vendor’s local personnel may not be accepted by the government. If requested by the government, the vendor will be required to identify an expert from their national office to travel to the designated VA site at no cost to the government to correct the equipment issue/s.

If the vendor is unable to correct the issue to the satisfaction of the dialysis center medical director within 10 business days of written notification from the government, the government will maintain the option of returning all the hemodialysis systems and obtaining a full refund from the vendor for the cost of all hemodialysis machines and supplies. The vendor will also be required to arrange and pay for the cost to return all defective hemodialysis systems from the government location to a location specified by the vendor.

The government will also maintain the option of requesting that the vendor replace all hemodialysis systems. If the government requests a replacement, the vendor will be required to immediately replace all hemodialysis systems and associated parts and supplies at no cost to the government. The vendor will also be required to arrange and pay for the cost to return all defective hemodialysis systems from the government location to a location specified by the vendor. Replacement of all of the hemodialysis systems must occur within 10 business days after the 10 business days allowed for the vendor to correct the issue has elapsed. The vendor will be liable to the government for each day of dialysis center non-operation resulting from malfunction of the hemodialysis systems at a cost of $5,500 per day of non-operation of a 12 station facility, $6,600 per day for non-operation of a 16 station facility, $7,600 for non-operation of a 20 station facility, $8,600 per day for non-operation of a 24 station facility, $10,000 per day for non-operation of a 28 station facility, $11,000 per day for non-operation of a 32 station facility, and $12,000 per day for non-operation of a 36 station facility. The vendor will also be liable for any construction costs associated with replacement of the hemodialysis systems.

5.3. Hemodialysis System Failure during Warranty Period:

During the two-year warranty period, if the government determines that the hemodialysis systems do not operate according to manufacturer specifications or are not safe to use in the treatment of patients, the government will notify the vendor. The vendor will have 5 business days to resolve all issues to the satisfaction of the government.

If the issues are not resolved within 5 business days; the vendor will be required to immediately replace the defective hemodialysis system/s at no cost to the government. The vendor will be liable to the government for each day of dialysis center non-operation resulting from malfunction of the hemodialysis systems at a cost of $5,500 per day of non-operation of a 12 station facility, $6,600 per day for non-operation of a 16 station facility, $7,600 for non-operation of a 20 station facility, $8,600 per day for non-operation of a 24 station facility, $10,000 per day for non-operation of a 28 station facility, $11,000 per day for non-operation of a 32 station facility, and $12,000 per day for non-operation of a 36 station facility. The vendor will also be liable for any construction costs associated with replacement of the hemodialysis systems.

6. Hemodialysis System Technical Specifications:

The following technical specification requirements are set forth for each hemodialysis system purchased by the VA under this contract. Each hemodialysis system purchased under this contract must have the following:

a. Must be a self-contained, microprocessor-controlled device that is capable of providing hemodialysis, hemofiltration, and ultrafiltration therapies.

b. Must consist of the hemodialysis machine with a blood tubing set designed for the hemodialysis system, a dialyzer, a heparin-filled syringe, sodium bicarbonate powder, and other appropriate dialysate concentrates.

c. Must be capable of carrying out the following therapies:

1) Ultrafiltration: In ultrafiltration, the body’s excess fluid is removed through the dialyzer membrane by means of a pressure gradient between the blood and dialysate compartments in the dialyzer.

2) Hemodialysis: In hemodialysis, the chemical composition of blood is corrected by removing accumulated metabolic products, normalizing ionic content and adding a buffer through the process of diffusive transport. In this case the concentration of solutes unwanted or to be cleared is lower or null in the dialysate with respect to the blood, causing these solutes to diffuse from a compartment of greater concentration (the patient’s blood) to a compartment of lesser concentration (the dialysate solution) across a natural or synthetic semi-permeable membrane. The body’s excess fluid is removed through the membrane by a means of a pressure gradient created by the hemodialysis systems. The entire hemodialysis process is managed by the hemodialysis system which monitors and controls the total ionic composition of dialysate solution together with the ultrafiltration process.

d. Must have built-in compensated blood flow tool that:

1) Allows actual blood flow compensated for negative arterial pressure.

2) Allows for the treatment to run at the prescribed blood flow rate.

3) Identifies arterial pressure issues by comparing the blood flow to the pump speed.

e. Must have built-in venous pressure monitoring system for monitoring of venous pressure and venous need dislodgement. System must be capable of triggering an alarm in case the patient’s venous pressure falls below the venous pressure alarm threshold set by the operator.

f. Must have built-in central monitoring system that:

1) Automatically calibrates each day.

g. Must allow for online mixing of dry bicarbonate and/or use of premixed bicarbonate solution.

h. Must have a cartridge and a cartridge blood set.

i. Must meet the following water supply requirements:

1) Must be able to meet local and AAMI standards for water quality.

j. Must have a waste handling option in which waste fluids go directly to the drain and is functionally integrated into the cartridge blood set.

k. Must meet the following informatics requirements:

1) Must be HL7 compatible and allow automated interface with CP Hemo.

2) Must have a standard Ethernet network connection.

3) Must allow for download of patient prescriptions to the hemodialysis system.

4) Must have on-screen charting capability.

l. Must have a color touch screen that shows:

1) Parameters and commands which the operator can select

2) Alarm messages

3) Operator messages

4) Status icons and pictograms

5) Navigation keys to access different views on touch screen

m. Must have a built-in or detachable keyboard that allows for chair-side charting.

n. Must have arterial and venous pressure monitoring system.

o. Must have timers for auto start to allow for integrated heat disinfection with the central reverse osmosis system.

p. Must have compensated blood flow.

q. Must allow UF and sodium profiling.

r. Must have blood pressure monitoring.

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

t. Must have ultrafilter holder.

u. Must have central concentrate connection.

v. Must have pH probe.

w. Must have a back-up battery kit.

x. The hemodialysis system must contain the following components:

1) Patient card reader

2) Display/Touch screen

3) Main control panel

4) Blood pump control panel

5) Multi-position line clamps with 2 or more clamps

6) Blood pump cover and cover latch

7) Blood pump

8) Air bubble detector

9) Patient sensor

10) Arterial line clip

11) Venous line clip

12) Waste handling option

13) Acid/Acetate line

14) Bicarbonate line

15) Disinfectant line

16) Concentrate Container Shelf

17) Locking brake

18) Heparin syringe holder

19) Heparin control panel

20) Heparin syringe plunger clamp

21) Blood leak detector

22) Blood pressure cuff holder

23) Blood panel latch

24) Main power switch

25) Sodium bicarbonate holder or bicarbonate port/connection which attach to a central bicarbonate supply or premixed bicarbonate container.

26) Solution bag hooks

27) IV pole adjustment knob

28) IV pole

29) Status lights

30) Ultrafilter detection switch

31) Hour meter

32) Computer interface panel

33) Ultrafilter bypass connector

34) Blood pressure tubing connector

35) Air vents

36) Blood pump crank

37) Cable holder

38) Wand holder

39) Chemical container shelf

40) Power cord

41) Inlet water hose

42) Drain hose

43) Dialysate line from dialyzer

44) Dialysate line to dialyzer

45) Cartridge holder

46) Dialyzer holder

47) Inlet water filter

y. The vendor will be responsible for ensuring proper connection and compatibility between the dialysis machines and the water treatment system utilized by the Government.

z. Miscellaneous items must include:

1) Regulatory documentation

2) Design specifications for the hemodialysis systems

3) Electronic and written standard operating procedures manual.

4) Complete service manual (electronic and written format).

5) 510K FDA certificate provided by the vendor to the government for each hemodialysis system confirming system functionality.

6) Vendor must conduct a minimum of a two week on-site training course on hemodialysis system use for all dialysis center staff. Training must include training on the system without patients being treated and training during actual patient treatments.

7) The vendor must provide annual refresher training to each VA site that purchases hemodialysis systems.

7. Hemodialysis System Warranty Requirements

The following set forth the warranty requirements for the hemodialysis systems procured under this SOW:

a. Warranty Period: The vendor must provide a minimum of a two year full on-site warranty period for each hemodialysis system procured under this solicitation. The warranty period will be two years from the date of VA acceptance of the hemodialysis systems (see Section 4.5 above for more information of VA hemodialysis system acceptance).

b. Warranty Services: The warranty will cover the cost associated with resolution of emergency and non-emergency issues identified by the dialysis center medical director that impacts dialysis center operations by expert officials from the vendor’s national or local office. Correction of issues by a vendor’s local representative may not be accepted by the government. In these situations, the vendor will be required to provide an expert from their national office to resolve all identified equipment issues.

c. Warranty Response Time: The vendor shall provide a verbal response within 30 minutes of dialysis center notification of a service issue and/or request. If the dialysis center medical director indicates the service issue and/or request is an emergency that prohibits the operation or delivery of safe hemodialysis treatment to patients, the vendor shall provide on-site response within four hours of notification from the dialysis center. If the vendor determines that a replacement part or supply is needed to correct the emergency issue, the vendor shall execute an emergency order for the required part/s and arrange for expedited shipment and delivery of part/s needed to correct emergency situations. The vendor shall provide on-site service and repair within 24 hours for all non-emergency repair services.

d. Warranty Cost and Quote: The warranty will include all costs associated with parts, labor, supplies, vendor travel, recommended preventive maintenance services, emergency and non-emergency maintenance services. The cost of the warranty period may not be billed separately and should be included in the vendor’s quote for the cost of each hemodialysis system. During the warranty period, the vendor must provide all emergency and non-emergency services, equipment, labor, supplies, and travel at no cost to the government.

8. Hemodialysis System Maintenance Service Technical Specifications

a. Hemodialysis System Maintenance Contract: Following conclusion of the two year all inclusive warranty period, the government will maintain the option of purchasing a maintenance service contract from the vendor for completion of all required corrective and preventive maintenance services. In submitting their response, the vendor must identify all required maintenance services for the hemodialysis system and the recommended frequency of performance of each service as specified in manufacturer guidelines.

Preventive maintenance (PM) shall include, but is not limited to:

1) The inspection and testing of the equipment to determine if any repair or maintenance is required or recommended for the equipment.

2) Acquisition of any required “PM kits” needed to perform and complete the required preventive maintenance.

3) PM shall be performed on equipment per specification by a manufacturer certified service person.

4) Should a unit require repair, and need longer than 3 business days for repair, it is the responsibility of the vendor to provide a loaner unit of the same generation by the third day to support continued patient care.

5) A documentation package will be maintained by the contractor and made available to the VA facility. The documentation package will be acceptable for Joint Commission purposes. Required features include at minimum:

i. Serial Number of equipment serviced

ii. Any and all work performed on a particular date

iii. Preventive Maintenance: The contractor will provide the written procedures followed and documented evidence that each piece of equipment has been inspected according to those procedures.

b. Maintenance Contract Price: As identified in Section 4 above, the vendor shall provide the following in their response to this SOW:

1) All required preventive and corrective maintenance services for each hemodialysis system, recommended frequency of performance, and parts and supplies required for performance.

2) All equipment, parts, labor, and travel in the annual preventive maintenance contract.

9. Response Time and Vendor Support

The vendor will be required to provide the below response times when responding to emergency and non-emergency hemodialysis system maintenance requests identified by the government.

a. Response Time for Emergency Services: The vendor shall provide a verbal response within 30 minutes of dialysis center notification of a service issue and/or request. If the VA indicates the service request is an emergency that prohibits the delivery of safe hemodialysis treatment to patients, the vendor shall provide on-site response within four hours of notification from the government. If the vendor determines that a replacement part or supply is needed to correct the emergency issue, the vendor shall execute an emergency order for the required part and arrange for expedited shipment and delivery of part/s needed to correct emergency situations.

b. Response Time for Non-Emergency Services: The vendor shall provide on-site service and repair within 24 hours for all non-emergency repair services.

c. Phone Support: The vendor will be available for consultation by phone about the operation, maintenance, or troubleshooting of the system when needed 24 X 7.

10. Work Requirements

a. Required Standards: The vendor will be responsible for ensuring that the services provided meet the equipment’s manufacturer’s guidelines and national dialysis standards, such as AAMI and Centers for Medicare and Medicaid (CMS) guidelines.

b. Evaluating Deliverables: The VA dialysis center medical director, nurse manager, and associated biomedical engineering staff will be responsible for evaluating vendor hemodialysis system functionality and vendor response and performance of maintenance services to ensure all systems and activities allow for the safe delivery of hemodialysis treatment to VA patients.

c. Supplies and Equipment: The vendor will be responsible for supplying and bringing any new materials required to complete corrective and preventive maintenance services to the VA dialysis centers, for installing all parts, for disposing of the old material, and for providing and placing labels on the part that was serviced by the vendor, stating the date of the service, and the servicer’s initials.

11. Government Furnished Property:

Government furnished property will not be provided to the contractor. All equipment required by the contractor will provided at their expense.

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