ATTACHMENT F – STATEMENT OF WORK

HEMODIALYSIS MACHINES, MANAGEMENT SOFTWARE,

AND MAINTENANCE SERVICES
 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

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 any VA site throughout the United States including Alaska, Hawaii, and
Puerto Rico that provides dialysis treatments to Veterans. This requirement includes
the hemodialysis machines, the dialysis management 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, dialysis management software, and maintenance services. All equipment,
software, and services shall be in accordance with the specifications defined or
identified in this SOW. A summary of the required equipment, management software,
services, and documentation are 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 training on the operation and use of the dialysis machines from
the clinician’s (user/operator) perspective; and clinician refresher training;
2.3 Factory-level service training for the VHA biomedical engineers and
technicians; and the hemodialysis machines complete service manual and
documentation;
2.4 A two-year warranty for each dialysis machine;
2.5 Full service maintenance (preventive and corrective) for dialysis machines
procured under this contract; and for existing dialysis machines;
2.6 Turnkey solution for dialysis management software including delivery,
installation, testing, integration, documentation, and full functionality
demonstration of the management software with the dialysis machines and with
VA’s records and reporting system to include all hardware and software
requirements;
2.7 Management software turnkey solution includes annual corporate site licenses,
software updates for full compatibility with the hemodialysis machines and the
VA’s Computerized Patient Record System (CPRS), help desk support,
troubleshooting, documentation, and training;

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

2.8 Documentation to include regulatory documentation, test reports, and Food and
Drug Administration (FDA) 510(k) certification; hemodialysis machine operation
and user’s guide(s); complete factory-level service manual for the dialysis
machines; management software installation guide; management software
installation, operation, use and troubleshooting procedures; and service
reports; and
2.9 Trade-in and disposal of hemodialysis machines that are replaced or no longer
needed by the Government.

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=361&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 Clinical Procedures Hemodialysis Module (CP Hemo) standards interface; CP
V. 1.0 Hemodialysis Module; Patch MD *1.0*6; dated May 2008
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&
cad=rja&uact=8&ved=0CB0QFjAA&url=http%3A%2F%2Fwww.va.gov%2Fvdl%
2Fdocuments%2FClinical%2FClinProc%2Fmd_1_p6_ig.doc&ei=KHTFU7u_IcG
C8QG0kYCACg&usg=AFQjCNFL_FNydQtoGqvCC9n9izH4vpKpxw
3.9 Hemodialysis machine manufacturer’s specifications; and
3.10 Management Software specifications

4. Tasks and Requirements

The Contractor shall deliver, install, activate, calibrate, and test hemodialysis machines;
and deliver, install, test, integrate and fully demonstrate the dialysis management
software at any VA location including Alaska, Hawaii, and Puerto Rico, that requires
outpatient dialysis care. Refer to the following website for locations that perform
dialysis. http://www.va.gov/health/services/renal/dialysis.asp. The Contractor shall

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

deliver hemodialysis machines, management software, training, two-year warranty, and

maintenance (both preventive and corrective) that meet all requirements in this SOW.
The Contractor shall deliver the associated documentation as described in Table 4 of
this SOW.

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 and expiration dates as
well as all 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, management software sales and
version per installation and for any 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 for the
hemodialysis machines and management software. The Contractor shall perform all
maintenance, remove all failed or used parts, and install replacement parts. The
contractor shall dispose of old material, and provide and place labels on the part(s)
and machine to indicate the item was serviced or modified. In addition, the
Contractor shall retest and certify the repairs or maintenance action results are
within the manufacturer’s specifications and guidelines. Refer to the Service Report
documentation requirements.

4.3 Operating Hours, Capacity, and Status Definitions

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

4.3.1 Hours of Operation

The Contractor shall recognize the VA dialysis center hours of operation shown in
Table 1 below.

Table 1. Dialysis Center Hours of Operation

(Approximate) Hours of Operation Days of Operation *
Two (2) Late Evening - 6:00 Monday -
Early morning - 5:00 am
Shifts pm Saturday
Three (3) Monday -
Early morning - 5:00 am Night - 9:00 pm
Shifts Saturday

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

Table 1. Dialysis Center Hours of Operation

(Approximate) Hours of Operation Days of Operation *
* Centers Operate All Federal Holidays except Thanksgiving Day,
Christmas Day, and New Year’s Day.

4.3.2 Patient (Operating) Capacity

The Contractor shall maintain equipment to meet 100% patient capacity also
referred to as operating capacity. The operating capacity of the dialysis center is
based on the number of dialysis stations and the number of operating shifts as
shown in Table 2 below. To maintain 100% capacity, additional dialysis machines
are planned as backup or spare units as shown in Table 2.

Table 2. VA Dialysis Center Patient Capacity or Operating Capacity

Operating capacity (# of Operating capacity (# of
# of Dialysis Machines – Mission Essential
patients) for two (2) patients) for three (3)
(excluding isolation)
patient-shifts per day patient-shifts per day
Number of spare
Number of Machines Number of patients Number of patients
machines
12 3 48 72
16 4 64 96
20 5 80 120
24 6 96 144
28 7 112 168
32 8 128 192
36 9 144 216

4.3.3 Operating Capacity Status Ratings

The Operating Capacity Status Ratings are described in Table 3. As defined below,
all mission essential machines must be fully operational with the status determined
by the operational availability of the spare or backup machines. The Contractor shall
ensure that backup or spare machines are operational and shall provide a schedule
to perform all maintenance and servicing to maintain non-emergency status.

Table 3. Operating Capacity Status Ratings

Status
Definition
Indicator
Green 100% of all mission essential hemodialysis machines are fully
operational; and
Seventy-five (75%) percent or more of the onsite, backup hemodialysis
machines are fully operational.
Yellow 100% of all mission essential hemodialysis machines are fully
operational; and
Less than 75% of the onsite, backup hemodialysis machines are fully
operational.

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

Table 3. Operating Capacity Status Ratings

Status
Definition
Indicator
Red 100% of all mission essential hemodialysis machines are fully
(Emergency) operational; with no operational on-site, backup hemodialysis machines.
Black Less than 100% of mission essential hemodialysis machines are
(Critical operational.
Mission
Impact) Denotes a condition where outsourcing hemodialysis treatments will be
necessary. Liquidated damages will apply.

4.3.4 Mission Essential

Mission essential is defined as the required number of hemodialysis machines a site
must have to be at 100% operating capacity for patient treatments. See Table 2
above.

4.3.5 Non-operational
A hemodialysis machine is non-operational when a fault or condition makes the
hemodialysis machine unable to perform to the manufacturer’s specifications, unable
to meet its intended function, and/or is unsafe for patient care/treatments.

4.3.6 Backup (Hemodialysis Machine)

A “backup” is defined as reserve or “spare” hemodialysis machine that is above and
beyond the required Mission Essential number of machines for patient treatments at
100% operating capacity at a given site. See Table 2 above.

4.3.7 Emergency
Emergency status is based on the operating capacity status shown in Table 3
above. Defined by the status indicator of “Red,” an emergency is when only the
mission essential dialysis machines are operational, and there are no onsite, backup
dialysis machines that are operational.

4.3.8 Non-emergency
Non-emergency status is based on the operating capacity status shown in Table 3
above and as defined by the status indicators of “Green” and “Yellow.”

4.4 Delivery and Delivery/Task Orders

The Contractor shall deliver the hemodialysis machines, management software,
training, and maintenance services to the VA site identified in the individual order or
task order (DO). The DO/TO will be placed by the VA requiring offices and will
include:

a. Delivery location
b. Quantity
c. Requested delivery date and time

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

d. Contracting Officer’s Representative (COR)

e. Dialysis Center Medical Director (DCMD)

4.4.1 Delivery and Service Coordination

The Contractor shall coordinate with the Contracting Officer’s Representative (COR)
and Dialysis Center Medical Director (DCMD) to identify a time when the dialysis
machine(s) and/or management software are to be delivered, installed, serviced, or
maintained that minimizes disruption to patient treatment.

4.5 Response Time and Telephone Support

The Contractor shall comply with the following response times and telephone
support requirements. The Contractor shall apply these response times to all
machines, management software, and services purchased under this contract
including the warranty period, software licenses/support, and full service
maintenance.

4.5.1 Response Time for Emergency Services

The Contractor shall provide a verbal response within four (4) hours of dialysis
center notification of an emergency service issue and/or request. The Contractor
shall provide on-site response within one (1) business day of notification. If the
Contractor determines that a replacement part or supply is needed to correct the
issue, the Contractor shall arrange for and cover all costs for expedited shipment
and delivery of the needed parts or supplies as part of the emergency repair. The
Contractor shall complete the repairs and have the machine(s) operational within 10
business days of the reported emergency.

4.5.2 Response Time for Non-Emergency Services

The Contractor shall provide a verbal response within twenty four (24) hours of VA
notification of a service issue and/or request. The Contractor shall provide on-site
services and repairs within three (3) business days for all non-emergency repair or
service requests. The Contractor shall complete the repairs and have the
machine(s) operational within 14 business days from the reported non-emergency
event.

4.5.3 Telephone Support

The Contractor shall be available for consultation by telephone regarding the
operation, maintenance, or troubleshooting of the dialysis machines and
management software during dialysis center operating hours.

4.6 Hemodialysis Machines – Delivery, Installation and Testing

The Contractor shall perform the installation, testing, calibration and certification of
the hemodialysis machines. The Contractor shall ensure that the company
representatives performing the installation, testing and maintenance are factory-
trained and certified experts in the hemodialysis machines. The Contractor shall not
delegate such tasks to a local company representative that is not a certified expert in

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

the hemodialysis machine operation, use, testing, calibration and maintenance. The
Contractor shall deliver the Operator’s Manual, User’s Guide and any related
procedures with the hemodialysis machines.

4.6.1 Hemodialysis Machine Connections and Compatibility

The Contractor shall be responsible for the operation and all connections of the
hemodialysis machine from the wall box connection through the dialysis machine
and to the patient. The Contractor shall ensure proper connection and compatibility
between the dialysis machines and the water treatment system used by each VA
site. Also refer to Section 4.2 of this SOW for required materials and supplies.

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

4.6.3 Hemodialysis Machine Baseline Testing

The Contractor shall ensure coordination with the COR and DCMD to establish a
mutual date (no later than five (5) business days after delivery) and time for baseline
testing to begin that enables VA personnel to observe 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 with a FDA 510K certificate and 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.

4.6.4 Government Acceptance Testing

The DCMD and 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 the
completion of Contractor’s 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, certification that all FDA and
regulatory requirements are met, and the machines are safe to treat patients;

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

b. Government acceptance testing is successfully completed and/or all issues

have been resolved;
c. Hemodialysis machines meet and operate according to the manufacturer’s
specifications and AAMI guidelines;
d. Hemodialysis machines are certified and verified safe for patient
use/treatments;
e. Hemodialysis Operations and User’s manuals and guides are delivered to the
site; and
f. The Contractor’s initial operator/user training has been successfully
completed.

4.7 Hemodialysis Machine - Warranty

The Contractor shall provide the following warranty for dialysis machines. As part of
the warranty services, the Contractor shall ensure that each site’s Patient Capacity
or Operating Capacity is maintained at 100%. Refer also to Section 4.2 of this
SOW.

4.7.1 Warranty Services

Hemodialysis Machines purchased under this contract shall be brand new, free from
defects in materials and workmanship, and shall include a two (2) year warranty.
The warranty period will be specific to each machine, and shall begin upon VA site’s
acceptance of each Hemodialysis Machine. The Contractor’s warranty shall include
product support for the purchased Hemodialysis Machines to ensure the system is
operating at optimum performance levels, and is in conformance with product
specifications, and free from all defects. The warranty shall include support, all
parts, supplies, materials, tools and labor at no additional cost to the VA for the
duration of the warranty period. 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 service and certify that the system is fully
operational after such repair or service. The Contractor shall coordinate with each
VA Site to schedule service for the Dialysis Machines.

4.7.2 Warranty and Service Reporting

The Contractor shall prepare a service report and provide it to the COR at the
conclusion of the warranty service or other warranty maintenance and repair. The
Contractor shall ensure all maintenance services performed are fully documented
(service reports) to include the following information.
a. The Machine 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. Describe all work performed and identify 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;
and

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

f. Provide and place labels on the part and machine to indicate that the
item/machine was serviced.

4.8 Hemodialysis Machine - Full Service Maintenance

The Contractor shall provide the VA with one-year (12 months) of full maintenance
services (corrective and preventive) for dialysis machines procured under this
contract in accordance with the manufacturer’s specifications. As part of the full
service maintenance requirements, the Contractor shall ensure that the Patient
Capacity or Operating Capacity is at 100% as stated in Section 4.2 of this SOW.
The Contractor shall maintain the hemodialysis machines and management software
in proper operating condition, and assure optimum performance and reliability as
well as the overall safety of the patients.

For VA sites with existing dialysis machines (not procured under this Contract), the
Contractor shall provide full maintenance services (preventative and corrective) for
that existing hemodialysis equipment. The Contractor shall provide full maintenance
services for existing hemodialysis machines indicated in Attachment E. Attachment
E – Existing Hemodialysis Equipment Inventory provides the list of manufacturers,
the associated age of the equipment, and the locations.

4.8.1 Preventive Maintenance

The Contractor shall perform all preventive maintenance at the recommended
frequency specified in manufacturer’s guidelines, specifications, manuals and other
applicable standards in Section 3 Applicable Documents of this SOW.

4.8.2 Corrective Maintenance

The Contractor shall perform all corrective maintenance services per manufacturer’s
specifications within the required response time (emergency or non-emergency).
The Contractor shall use factory-trained and certified experts to perform the
maintenance.

4.8.3 Inspect, Test, and Document

The Contractor shall inspect and test all dialysis machines to determine if any repair
or maintenance is required or recommended, and to certify that the maintenance or
repair was successful. The Contractor shall ensure all maintenance services
performed are fully documented (service reports) to include the following
information.
a. The Machine 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. Describe all work performed and identify 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;

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

and Provide and place labels on the part and machine to indicate that the
item/machine was serviced.
f. Provide and place labels on the part and machine to indicate that the
item/machine was serviced.

4.9 Management Software – Installation and Demonstration

The Contractor shall provide a turn-key solution including the installation, integration,
interface, and full functional demonstration of the management software with the
hemodialysis machines and the CPRS at each VA site. 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. Also refer to
Section 4.2 of this SOW for required materials and supplies. The Contractor shall
deliver the management software Installation guide and procedures (e.g., quick
guide) prior to installation.

4.9.1 Management Software Installation, Test and Demonstration

The Contractor factory-trained and certified expert(s) shall install, test, integrate and
fully demonstrate functionality of the management software including functions from
and to the hemodialysis machines and the CPRS. The Contractor shall provide all
hardware, cables, software, and equipment needed to fully integrate the software
with the hemodialysis machines and the CPRS. The Contractor shall ensure that
the software performs to the manufacturer’s specifications; and ensure proper setup
and installation with the hemodialysis machines and with any interface connections
to include the CPRS. The Contractor shall ensure that the latest software
configurations are identified, installed, and recorded to ensure proper tracking of
software. The Contractor shall provide test reports and certify completion of testing
to include certification that the software meets all requirements, and documentation
of the exact software version(s) installed. Refer also to Section 4.2 and Table 4 in
this SOW. The Contractor shall deliver the management software operator’s and
user’s guide and procedures at the time of installation.

4.9.2 Management Software Acceptance Testing

The DCMD and dialysis center staff will conduct testing and evaluation of the
management 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
management software no later than 10 calendar days from the completion of
Contractor’s installation and demonstration.

The acceptance of management software will include the following:

a. Contractor completion of management software testing, certification that the
software is operating to specifications;
b. Contractor completion of full functionality demonstration between the
hemodialysis machines and the CPRS;

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

c. Government acceptance testing is successfully completed and/or all issues

have been resolved;
d. User training by the Contractor has been successfully completed, and
e. The dialysis staff is trained to independently use, chart, and identify,
troubleshoot and report software problems of the management software
between both the hemodialysis machines and the CPRS.

4.10 Management Software - Site Licenses/Support

The Contractor shall provide a turnkey solution for the management software that
includes site license to use and operate the software on all hemodialysis machines
within a dialysis center or facility, and interface with the CPRS. The Contractor shall
include all software updates, fixes, patches; and the associated documentation; and
troubleshooting assistance as part of the license agreement. The Contractor shall
ensure continued compatibility with the hemodialysis machines and the CPRS and
shall provide software updates and new releases as required to maintain
compatibility with the dialysis machines and CPRS. The Contractor shall document
all service and software updates to include the exact software version installed and
any associated documentation (e.g.; user updates, procedures). Refer also to
Section 4.2 and Table 4 in this SOW.

4.10.1 Management Software Support

The Contractor shall provide help desk support during dialysis center operating
hours. The Contractor shall provide response/service to correct or remedy issues in
accordance with the emergency or non-emergency response times. The Contractor
shall provide on-site support in the case that the software is inoperable or unable to
be resolved via the help desk/telephone support.

4.11 Training Requirements

The Contractor shall provide the following training for the hemodialysis machines
and dialysis management software.

4.11.1 Hemodialysis Machine User Training

The Contractor shall conduct the initial operator and user training with the
hemodialysis machine site delivery and installation. 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 center 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 and user
training for new staff on an as-needed basis.

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

4.11.2 Hemodialysis Machine Refresher Training

The Contractor shall provide on-site (or alternate delivery) refresher training on the
operation and use of the dialysis machines. The Contractor shall coordinate the
refresher training with the COR for each delivery site.

4.11.3 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. 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.

4.11.4 Hemodialysis Management Software Initial Training

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

5. Hemodialysis Machine and Management Software Technical Requirements

The Contractor shall provide hemodialysis machine and management software that
meets the respective Technical Requirements (TRs). The Contractor shall ensure that
the equipment and services provided meet manufacturer’s specifications, FDA 510 (k)
compliance requirements, and National Dialysis Standards such as 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 technical requirements (TRs).
1. Shall be a self-contained, microprocessor-controlled device capable of providing
hemodialysis, hemofiltration, and ultrafiltration (UF) therapies.
2. 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.
3. Shall be capable of carrying out the following therapies:
1) Ultrafiltration (UF): 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; and
2) Hemodialysis: In hemodialysis, the chemical composition of blood is
corrected by removing accumulated metabolic products, normalizing ionic

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

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 dialysis machines. The entire hemodialysis process is managed by
the dialysis machine, which monitors and controls the total ionic
composition of dialysate solution together with the ultrafiltration process.
4. Shall 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; and
3) Identifies arterial pressure issues by comparing blood flow to pump speed.
5. Shall have built-in venous pressure monitoring system for monitoring of venous
pressure and venous needle dislodgement. The hemodialysis machines shall be
capable of triggering an alarm in case the patient’s venous pressure falls below
the venous pressure alarm threshold set by the operator.
6. Shall have built-in central monitoring system that automatically calibrates each
day (at a minimum and per manufacturer’s specifications) and can be manually
initiated as needed.
7. Shall allow for online mixing of dry bicarbonate and/or use of premixed
bicarbonate solution.
8. Shall have a cartridge and a cartridge blood set.
9. Shall meet local and AAMI standards for water quality.
10. Shall have a waste handling option, in which waste fluids go directly to a drain,
and is functionally integrated into the cartridge blood set.
11. 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.
12. Shall have a built-in and/or detachable keyboard that allows for chair-side
charting.
13. Shall have arterial and venous pressure monitoring system.
14. Shall have timers for auto start to allow for integrated heat disinfection with
central reverse osmosis (RO) system.
15. Shall allow for UF and sodium profiling.
16. Shall have blood pressure monitoring.
17. Shall have sodium bicarbonate cartridge and/or bicarbonate line/connector that
attaches to a central bicarbonate supply or premix bicarbonate container.
18. Shall have ultrafilter holder.
19. Shall have central concentrate connection.
20. Shall have pH probe.

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

21. Shall have a back-up battery kit.

22. Shall contain the following components:
1) Display/touch screen
2) Main control panel
3) Blood pump control panel
4) Multi-position line clamps with 2 or more clamps
5) Blood pump cover and cover latch
6) Blood pump
7) Air bubble detector
8) Patient sensor
9) Arterial line clip
10) Venous line clip
11) Waste handling option
12) Acid/Acetate line
13) Bicarbonate line
14) Disinfectant line
15) Concentrate Container Shelf
16) Locking brake
17) Heparin syringe holder
18) Heparin control panel
19) Heparin syringe plunger clamp
20) Blood leak detector
21) Blood pressure cuff holder
22) Blood panel latch
23) Main power switch
24) Sodium bicarbonate holder or bicarbonate port/connection that attaches to
a central bicarbonate supply or premixed bicarbonate container.
25) Solution bag hooks
26) IV pole adjustment knob
27) IV pole
28) Status lights
29) Ultrafilter detection switch
30) Hour meter
31) Computer interface panel
32) Ultrafilter bypass connector
33) Blood pressure tubing connector
34) Air vents
35) Blood pump crank
36) Cable holder
37) Wand holder
38) Chemical container shelf
39) Power cord
40) Inlet water hose
41) Drain hose
42) Dialysate line from dialyzer

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

43) Dialysate line to dialyzer

44) Cartridge holder
45) Dialyzer holder
46) Inlet water filter
23. Shall include all hoses and connectors to enable connection of the dialysis
machine to the wall box (Reverse Osmosis system water connection); and
24. Shall meet the following informatics requirements:
1) Shall be HL7 compatible and allow automated interface with CP Hemo.
2) Shall have a standard ethernet network connection.
3) Shall allow for download of patient prescriptions to the dialysis machine.
4) Shall have an on-screen charting capability.

5.2 Management Software Technical Requirements

The Contractor shall deliver and install hemodialysis management software that
provides a turnkey solution for the management of information between the
hemodialysis machines and the VA’s CPRS. In addition to the delivery, installation
and support requirements, the Contractor shall deliver a product that meets the
following TRs.
1. Shall include all required software and hardware, necessary for optimal functioning
and interface with the hemodialysis machines and the VA’sCPRS. (e.g., software
kits)
2. Shall have capability of collecting treatment data from the dialysis machine using
standard ethernet (CAT5).
3. Shall have capability of collecting data from the keyboard.
4. Shall have capability of storage of data in a secure database.
5. Shall have capability of displaying treatment data including pre-assessment, flow
sheet, and post-assessment
6. Shall allow users to print reports of treatment data.
7. Shall have capability of exporting treatment data to VA’s electronic medical record
(CPRS).
8. Shall have capability of documenting dialysis machine disinfection and rinses.
9. Shall have capability of operating in either stand-alone or client-serve modes.
10. Shall have capability of acquiring, processing, and supplying data required when
running a dialysis treatment.
11. 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.
12. Shall comply with all Government information security requirements and HIPAA
regulations. Refer to the VA Contract Security Requirements in the contract
clauses.

6. Government Evaluation and Monitoring

The DCMD and dialysis center staff will evaluate and monitor hemodialysis machine
and management software performance and conduct testing to include results during
and after patient treatments. The Government will verify that each dialysis machine

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

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 management software:
a. If changes to the equipment occur, the Contractor shall re-baseline and perform
requisite testing to ensure patient safety and machine functions to meet
specifications;
b. Results of government evaluation and monitoring;
c. Hemodialysis machines continue to operate according to manufacturer’s
specifications and AAMI guidelines;
d. The machines are safe and continue to remain safe for patient treatment (e.g.,
product recalls, FDA recalls, et al);
e. The hemodialysis machines continue to support Dialysis Center operations and
to meet the operating capacity;
f. The hemodialysis machines remain compatible with the management software
and the CPRS; and
g. The management software continues to support Dialysis Center operations and
remains compatible with the hemodialysis machines and the CPRS.

7. Documentation Requirements
The Contractor shall provide the documentation identified in Table 4 below. The
Contractor shall deliver the documents in electronic (e.g., searchable PDF, Microsoft
Office application such as Word or Excel) and/or hard copy (e.g., bound or notebook)
formats as specified below.

Table 4. Hemodialysis Machines, Management Software and Maintenance

Documentation Requirements
Description
Contract Management 4.1
Reports; Quarterly
Reports;
Tracking and
management reporting
SOW Reference Delivery Notes Deliver to
IDIQ Contract Reporting
Submit the first CO
quarterly report on (Electronic only
the 15th day after Excel)
the first full quarter
after contract
award. Submit
monthly on the 15th
day of each quarter
thereafter.
Contractor format
is acceptable.
Delivery Order Reporting

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

Table 4. Hemodialysis Machines, Management Software and Maintenance

Documentation Requirements
Description SOW Reference Delivery Notes Deliver to
Hemodialysis Machines; Sections 4.6 Submit hard copies COR (Site)
Operator and User’s and 4.6.4. for each site with (Three hard copies
Guide and Procedures the equipment and two electronic
delivery. Submit copies per site)
electronic copies
and updates per
machine if
integrated into
machine function.
Contractor format
is acceptable.
Hemodialysis Machines; Sections Submit no later Dialysis Center
Baseline Test Reports; 4.6.3 and than 4 hours after Medical Director
and FDA 510 4.6.4. the successful (DCMD)
Certification conclusion of (One hard copy
documentation. baseline testing for and one electronic
each hemodialysis copy)
Certification that the machine.
hemodialysis machine COR (site)
meets all specifications Contractor format (Electronic only)
and is safe to use for is acceptable.
patient treatments
Hemodialysis Machines; Sections Submit each time DCMD
Service Reports 4.7.2, and any maintenance (One hard copy
4.8.3. action is performed and electronic
Warranty and Full for any copy)
Service Maintenance hemodialysis
machine. COR (Site)
Submit NLT four (Electronic copy
(4) hours after only)
action is
completed.
Contractor format
is acceptable.
Hemodialysis Machines; Section Submit for each COR (Site)
Complete Service 4.11.3 site. (Two hard copies
manual and factory level and two electronic
service/repair Contractor format copies per site)
documentation. is acceptable.

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

Table 4. Hemodialysis Machines, Management Software and Maintenance

Documentation Requirements
Description SOW Reference Delivery Notes Deliver to
Hemodialysis Section 4.9. Submit at least 3 COR (site)
Management Software; business days (One hard copy
Installation Guide and before software and one electronic
Procedures (e.g., quick installation copy)
guide) Contractor format
is acceptable.
Hemodialysis Sections 4.9, Submit hard copies COR (site)
Management Software; and 4.9.1. with the software (Three hard copies
Operator and User’s delivery and and one electronic
Guide and Procedures installation for each copy per site)
site. Submit
electronic copy per
software
installation if
integrated into the
software function.
Contractor format
is acceptable.
Hemodialysis Sections Submit each time COR (Site)
Management Software; 4.10 and the management (One hard copy
Updates/Changes/ 4.10.1. software is updated and one electronic
Service Report(s) or changed copy)
Submit NLT twenty
four (24) hours
after installation
action is
completed.
Contractor format
is acceptable.

8. Equipment Trade-in and Disposal

In the event the Government requests to trade-in a previously purchased hemodialysis
machine as part of a purchase transaction for a new hemodialysis machines and the
Contractor agrees to take such trade, the Contractor and Government will determine fair
and reasonableness of the Trade-in Value prior to the issuance of the Task Order. The
Contractor shall remove and dispose of any existing hemodialysis machines identified in
the Delivery/Task Order under the Contract Line Item Number (CLIN) "Consideration for
Trade-in."

9. Subcontracting Plan
Contractor shall comply with Subcontracting Plan. If Contractor is unable to meet
Subcontracting goals, the Contractor shall contact the Contracting Officer and identify

Source Selection Information - See FAR 2.101 and 3.104

 Statement of Work
Hemodialysis Machines, Management Software,
and Maintenance Services

reason(s) why the Contractor is unable to meet Subcontracting goals. The Contracting
Officer and Contractor will reassess and establish new Subcontracting Plan if needed.

10. Travel
The Contractor shall be responsible for all travel costs incurred under this contract. The
VA will not reimburse any separate travel costs associated with this effort.

11. Government Furnished Property/Equipment/Information

The Contractor shall provide all equipment, tools, facilities, supplies, parts, and
materials to perform the tasks in this SOW. Government furnished property, equipment
or information are not required for this effort.This is an empty document

Source Selection Information - See FAR 2.101 and 3.104