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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-andGuidance/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

Two (2) Shifts Three (3) Shifts

Early morning - 5:00 am

Late Evening - 6:00 pm

Early morning - 5:00 am

Night - 9:00 pm

Days of Operation *

Source Selection Information - See FAR 2.101 and 3.104

Monday Saturday Monday Saturday

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 # of Dialysis Machines – Mission Essential (excluding isolation)

Operating capacity (# of patients) for two (2) patient-shifts per day

Operating capacity (# of patients) for three (3) patient-shifts per day

Number of Machines

Number of spare machines

Number of patients

Number of patients

12 16 20 24 28 32 36

3 4 5 6 7 8 9

48 64 80 96 112 128 144

72 96 120 144 168 192 216

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 Indicator Green

Yellow

Definition 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. 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 Indicator Red (Emergency) Black (Critical Mission Impact)

Definition 100% of all mission essential hemodialysis machines are fully operational; with no operational on-site, backup hemodialysis machines. Less than 100% of mission essential hemodialysis machines are operational. 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 factorytrained 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

SOW Reference

Contract Management Reports; Quarterly Reports; Tracking and management reporting

Delivery Notes

IDIQ Contract Reporting 4.1 Submit the first quarterly report on the 15th day after the first full quarter after contract award. Submit monthly on the 15th day of each quarter thereafter. Contractor format is acceptable. Delivery Order Reporting

Deliver to

CO (Electronic only Excel)

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; Operator and User’s Guide and Procedures

Sections 4.6 and 4.6.4.

COR (Site) (Three hard copies and two electronic copies per site)

Hemodialysis Machines; Baseline Test Reports; and FDA 510 Certification documentation.

Sections 4.6.3 and 4.6.4.

Submit hard copies for each site with the equipment delivery. Submit electronic copies and updates per machine if integrated into machine function. Contractor format is acceptable. Submit no later than 4 hours after the successful conclusion of baseline testing for each hemodialysis machine.

Certification that the hemodialysis machine meets all specifications and is safe to use for patient treatments Hemodialysis Machines; Service Reports

Contractor format is acceptable. Sections 4.7.2, and 4.8.3.

Warranty and Full Service Maintenance

Hemodialysis Machines; Complete Service manual and factory level service/repair documentation.

Section 4.11.3

Submit each time any maintenance action is performed for any hemodialysis machine. Submit NLT four (4) hours after action is completed. Contractor format is acceptable. Submit for each site. Contractor format is acceptable.

Dialysis Center Medical Director (DCMD) (One hard copy and one electronic copy) COR (site) (Electronic only)

DCMD (One hard copy and electronic copy) COR (Site) (Electronic copy only)

COR (Site) (Two hard copies and two electronic copies per site)

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

Hemodialysis Management Software; Installation Guide and Procedures (e.g., quick guide)

Section 4.9.

Hemodialysis Management Software; Operator and User’s Guide and Procedures

Sections 4.9, and 4.9.1.

Hemodialysis Management Software; Updates/Changes/ Service Report(s)

Sections 4.10 and 4.10.1.

Delivery Notes

Deliver to

Submit at least 3 business days before software installation Contractor format is acceptable. Submit hard copies with the software delivery and installation for each site. Submit electronic copy per software installation if integrated into the software function. Contractor format is acceptable. Submit each time the management software is updated or changed Submit NLT twenty four (24) hours after installation action is completed. Contractor format is acceptable.

COR (site) (One hard copy and one electronic copy)

COR (site) (Three hard copies and one electronic copy per site)

COR (Site) (One hard copy and one electronic copy)

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