ATTACHMENT A - SOW -- Final 6-14-2021.pdf

STATEMENT OF WORK

For

Dialysis Equipment, Systems and Associated Maintenance

Services and Consumables

Prepared By:

Strategic Acquisition Center

Department of Veterans Affairs 10300 Spotsylvania Avenue, Suite 400

Fredericksburg, VA 22408

March 19, 2021

Statement of Work - Dialysis Equipment, Systems and Associated Maintenance Services and Consumables

TABLE OF CONTENTS

1. BACKGROUND 1

2. SCOPE OF WORK 1

3. UNIVERSAL REQUIREMENTS FOR ALL SYSTEMS, SERVICES, AND

CONSUMABLES 1

4. ADDITIONAL REQUIREMENTS FOR LEASE/RENTAL SYSTEMS (FOR

HOME USE) 13

5. SYSTEM SPECIFIC MINIMUM TECHNICAL REQUIREMENTS (MTR) 14

APPENDICES

APPENDIX A: VA Facilities Performing Dialysis 23

APPENDIX B: Contract Deliverables Chart 26

APPENDIX C: VA INFORMATION AND INFORMATION SYSTEM SECURITY/

PRIVACY 29

APPENDIX D: VA 6550 APPENDIX A 37

1. BACKGROUND

The Department of Veteran’s Affairs (VA) Veterans Health Administration (VHA) requires dialysis equipment, systems, and associated training, maintenance services, and consumables for VA facilities and for individual Veteran home use throughout the United States that perform dialysis (refer to Appendix A). The requirement includes water purification and distribution systems (central and portable), integrated water purification and dialysate delivery systems, hemodialysis (HD) systems, Continuous / Extended Renal Replacement Therapy systems, and peritoneal dialysis (PD) systems. VA requires the option to purchase systems for in-center use and lease systems for home use. Properly functioning equipment is critical to VA’s ability to deliver high-quality and safe dialysis to Veterans with kidney failure.

2. SCOPE OF WORK

a. Contract Vehicle: The VA intends to establish multiple award Indefinite Delivery, Indefinite

Quantity (IDIQ) contracts to Contractors capable of providing one or more of the equipment, services, and consumables specified in this Statement of Work (SOW). The capability to furnish multiple systems is preferred, but not required.

b. Contract Duration: The contract period is one Multi-Year period of performance of 60-months

c. Extent of Obligation: The quantity of equipment and services purchased shall be at VA’s discretion. For each contractor awardee, the minimum contract IDIQ guarantee value is $2,000.00 and the maximum contract value is $50,000,000.00. The minimum guarantee of $2,000.00 per contract award shall be met by within the same Fiscal Year of the award.

d. Place of Performance: Delivery location shall be specified per Delivery/Task Order. There are 106 VA facilities that perform dialysis (refer to Appendix A). The capability to furnish systems, services, and consumables to the entire VA network of dialysis facilities in the United States including Alaska, Hawaii, and Puerto Rico is preferred, but not required. For each item, Contractor shall indicate coverage area.

e. Hours of Operation: VA dialysis facilities generally operate either two (5 a.m.-6 p.m.) or three (5 a.m.-9 p.m.) shifts per day, six days a week (Monday-Saturday). Contractors shall coordinate a time of service (typically after hours) with VA that minimizes disruption to patient care. VA dialysis facilities operate on all Federal holidays except Christmas.

3. UNIVERSAL REQUIREMENTS FOR ALL SYSTEMS, SERVICES, AND

CONSUMABLES: All systems, services, and consumables furnished through this contract (including leased systems) shall meet the following:

a. AAMI Standards: Shall meet the most recent standards as defined by the Association for the Advancement of Medical Instrumentation (AAMI).

b. FDA Clearance: Shall have FDA clearance as a medical device for dialysis.

c. Technology Refresh: Contractor shall only supply the latest generation of systems in compliance with FDA regulations for medical devices. All devices offered shall be state-of-the-art technology at the time of delivery. "State-of-the-art" is defined as the most recently designed components that are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Products with a manufacturer's planned obsolescence within the first year of contract award or with planned phase-out over next 3 years are not acceptable. If upgrades of devices, new accessory devices, or software become available after award of this contract, the Contractor may add or substitute them for the awarded items following evaluation and approval by the Contracting Officer of Record and/or designee upon mutual execution of a modification to this contract. The Contractor shall provide to the contracting officer the following information prior to the end of the contract annual review: a list of specific awarded items that shall be added or updated, product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/disadvantages of the items involved.

The Contracting Officer will provide the information to his or her designee for review and approval. Upon approval, the contract will be modified at the end of the annual review to acknowledge the updated items.

d. Energy Efficient: All systems shall have energy and water saving features and mitigate need for VA waste management.

e. Site Preparation: Contractor shall conduct an on-site visit to VA and identify all equipment installation requirements. Contractor shall document equipment installation requirements and provide report (PDF) of requirements to VA engineering and dialysis team within 24 hours of site visit. VA shall be responsible for completing all site preparation requirements including installation of required drains and hanging support requirements for the water system distribution loop. Central water systems shall be installed proximate to the dialysis treatment space and immediately accessible to dialysis staff.

f. Design: Contractor shall provide site/unit-specific design documents (drawings and specs) that include materials, equipment, electrical, plumbing, and water supply requested by VA site and compliant with VA standards, specifications, and codes. Contractor shall provide as-built drawings and documentation at the completion of work (PDF and hard copy) of the entire installed system installed at the VA site.

g. Installation: Contractor shall complete turn-key installation of the equipment once the site preparation is complete. Turn-key installation for the central water purification and distribution system shall include installation of water system and distribution loop. VA shall be responsible for mounting the water purification wall boxes to the cabinetry and any piping to the drain that is required.

h. Labeling: Contractor shall label all system components (including hoses and connectors) during installation and provide an electronic copy of all equipment labels with operational function, purpose, quality checks, and factors affecting operation and actions.

i. System Baseline Testing and Validation: Contractor shall activate the system on the date specified by the VA dialysis medical director or designee. In the event that the system cannot be immediately activated, the system shall be kept “dry”. Once the system is activated, Contractor shall conduct baseline testing in accordance with requirements stipulated in Section 3.0.o, Chemical, Microbial, and Endotoxin Contaminant Analysis Testing of this contract. Contractor shall provide a system validation report (PDF) to the dialysis medical director that includes test results and Contractor attestation that system meets AAMI standards for patient treatment. Payment shall not occur until the contractor has provided the system validation report and the report has been accepted by the VA dialysis medical director. In the event testing results are abnormal, VA shall extend the testing timeline. Baseline testing shall consist of:

1) Central Water Purification and Distribution Systems

a) AAMI Chemical Contaminant Analysis: Source water and product water (baseline)

b) AAMI Microbial and Endotoxin Contaminant Analysis: Product water, post endotoxin filter, and end of distribution loop (weekly for four weeks)

2) Portable Water Purification and Distribution Systems

a) AAMI Chemical Contaminant Analysis: Product water (baseline)

b) AAMI Microbial and Endotoxin Contaminant Analysis: Product water (weekly for four weeks)

3) Portable Integrated Dialysis Water Purification and Dialysate Production Systems

a) AAMI Chemical Contaminant Analysis: Product water (baseline)

b) AAMI Microbial and Endotoxin Contaminant Analysis: Product water and dialysate

(weekly for four weeks)

4) Hemodialysis Systems

a) AAMI Chemical Contaminant Analysis: Dialysate fluid panel from all hemodialysis systems (baseline)

b) AAMI Microbial and Endotoxin Contaminant Analysis: Dialysate from all hemodialysis systems (weekly for four weeks)

j. Warranty:

1) Equipment: System shall be brand new, free from defects in materials and workmanship, and include a minimum of a one (1) year warranty that begins upon date of VA acceptance of the Contractor’s system validation report. The warranty shall include all services and supplies necessary to ensure the system operates at optimum performance levels, conforms with product specifications, and is free from all defects.

Warranty shall include but not be limited to all services and supplies specified in the all-inclusive maintenance agreement and all parts, labor, and on-site service and repairs at no additional cost. VA shall notify the Contractor in the event VA determines that the system does not operate according to manufacturer specifications, does not meet AAMI standards, or is not safe to use to treat patients. Contractor shall meet response times specified in Section 3.0.n, Response Times and Telephone Support of this contract. Contractor shall arrange for over-night delivery of all parts and supplies.

Contractor shall have five (5) business days from date of VA notification to correct all defects to VA’s satisfaction.

2) Parts: Warranty period for parts provided by Contractor shall be one (1) year from date of installation by Contractor or, if not installed by Contractor, one (1) year from the date of delivery.

3) Service: Warranty period for service performed by Contractor shall be one (1) year from performance of service completion date.

k. Contractor Liability:

1) System Defects For Systems Under Warranty: In the event the Contractor is unable to correct the issue and return the system to proper working order in accordance with (IAW) the requirements of the SOW, the Contractor shall replace the entire system and associated parts and supplies at no cost. Liquidated damages shall be assessed at $5,000 per calendar day per patient (i.e. each day issue is not corrected) (see FAR clause 52.211-11, Liquidated Damages-Supplies, Services, or Research and Development) once the five (5) calendar days allowed to the Contractor to correct the issue has elapsed.

2) Direct Damages: Contractor shall be liable for direct damages to a center or property due to floods or leaks caused by or related to the systems and services provided hereunder, provided that such damages are the result of a defect in the system, or negligence, or willful misconduct of the Contractor.

l. System Documentation: Upon installation of any equipment, Contractor shall provide:

operating manual, operator training manual, complete service manual including the maintenance schedule and procedures for preventative and corrective maintenance, pre and post installation checklists, procedures for disinfection of new system prior to activation, maintenance-service training manual, standard operating procedures (SOPs), FDA clearance letter, and technically related documents based on the manufacturers documented and validated instructions. Contractor shall update documents as necessary, highlighting areas that have been revised. For each document, one (1) electronic copy (searchable PDF) and one (1) hard copy (e.g., bound or notebook, etc.) shall be provided.

m. System Training:

1) User Training (on-site): The Contractor shall provide initial on-site user training on the operation, care, handling, set-up, and cleaning. Online or virtual education may be provided in addition to in-person instruction. Two additional on-site refresher training shall be provided per year at no additional cost.

2) Maintenance/Factory-Service Training (on-site): The Contractor shall provide initial on-site training on full system maintenance. Two additional on-site maintenance training shall be provided per year at no additional cost.

3) Maintenance/Factory-Service Training (off-site) (optional): The Contractor shall provide off-site training on full system maintenance when available. Two additional off-site maintenance training shall be provided per year at no additional cost.

n. Response Time and Telephone Support:

1) Emergency Service Support: For issues deemed emergencies by VA (such as work stoppage that requires diversion/cancellation of patient care), Contractor shall provide a verbal response within 30 minutes and an on-site response within eight (8) hours for continental United States (CONUS) locations and twenty-four (24) hours for outside the continental United States (OCONUS) locations from time of VA notification. Contractor shall arrange for over-night delivery of requested parts and supplies at no additional charge.

2) Non-Emergency Service Support: Contractor shall provide a verbal response within 30 minutes and on-site response within twenty-four (24) hours for CONUS locations and seven (7) calendar days for OCONUS locations from time of VA notification.

3) Telephone Support: Contractor shall be available for consultation by telephone 24 hours a day, 7 days a week, 365 days a year.

o. Chemical, Microbial, and Endotoxin Contaminant Analysis Testing:

1) AAMI Standards: Contractor shall test in accordance with the most recent AAMI standards at time of testing and shall utilize a laboratory capable of testing to AAMI standards.

2) Endotoxin Testing: Limulus Amoebocyte Lysate (LAL) assaying technique shall be used for endotoxin concentration testing. The sensitivity of the assay (lower limit of detectability) shall be less than or equal to 0.01 endotoxin units (EU)/milliliter (ml).

3) Sample Collection: For baseline testing, Contractor shall collect and send samples.

For on-going testing agreements, VA shall collect and send samples.

4) Training: Contractor shall provide written instructions (PDF) and on-site training of VA personnel on requirements for packaging and shipping of samples. On-site training shall be provided as requested.

5) Supplies: Contractor shall furnish supplies and shipping materials, including specimen tubes/containers, pre-paid and pre-labeled shipping labels with addressee information, shipping icepacks, and shipping containers/boxes at no additional cost. Supplies shall be provided every 3 months or upon request.

6) Documentation of Test Results: Contractor shall provide VA with official reports (PDF) of test results via email within 24 hours upon receipt from the laboratory.

7) AAMI Chemical, Microbial, and Endotoxin Contaminant Testing Agreement Purchase Options: VA shall have the option to purchase a testing agreement from Contractor/s when available. Testing agreements as follows:

a) Central Water Purification and Distribution Systems Testing Agreement

1. AAMI Chemical Analysis: Source water (annually) and product water (as requested and at a minimum annually)

2. AAMI Microbial and Endotoxin Analysis: Product water, post endotoxin filter, and end of distribution loop (monthly)

b) Portable Water Purification and Distribution Systems Testing Agreement

2. AAMI Microbiological and Endotoxin Analysis: Product water (monthly)

c) Portable Integrated Dialysis Water Purification and Dialysate Production Systems Testing Agreement

2. AAMI Microbiological and Endotoxin Analysis: Product water and dialysate (monthly)

d) Hemodialysis Systems Testing Agreement

1. AAMI Microbiological and Endotoxin Analysis: Dialysate from a minimum of 20% of all hemodialysis systems (monthly) with each system tested at least once per year.

p. Maintenance Service Agreement Purchase Options: VA shall have the option to purchase the following maintenance service agreements for systems procured through this contract (new) and for systems purchased prior to this contract (existing) from Contractor/s when available Service shall include all consumables, parts, on-site labor, travel, and supplies at no additional cost.

1) All-Inclusive Maintenance Agreement

a) All recommended manufacturer planned and corrective maintenance services, parts, and consumables to ensure system operates according to manufacturer specifications, meets AAMI standards, and is safe to use to treat patients (system-specific list and frequency provided by Contractor)

b) Emergency Service On-Site Support 24/7/365

c) Purchase of an all-inclusive maintenance agreement shall include the associated system AAMI chemical, microbial, and endotoxin contaminant testing agreements specified in Section 3.o.7.

2) A La Carte Maintenance Services and Consumables: Separately priced list of scheduled (i.e. preventative) and unscheduled (corrective) maintenance services, parts, and consumables to ensure system operates according to manufacturer specifications, meets AAMI standards, and is safe to use to treat patients (system-specific list and frequency provided by Contractor)

q. Service Documentation: Contractor shall provide a hard copy service report upon service completion and a searchable PDF electronic service report within 5 business days of service completion. Report shall be provided to VA dialysis medical director, biomedical engineer, and/or designee. Service report shall include device model and serial number of equipment serviced, date and time called, time of arrival, reason for call, work performed, parts replaced, whether system was disinfected after service, name of technician performing work, written procedures followed, and evidence that equipment has been inspected according to those procedures.

r. Trade-In Equipment: Contractor shall provide credit for Contractor-accepted, trade-in dialysis equipment with the purchase of new dialysis equipment.

1) In instances where sanitization of ePHI compromises the operating system (OS) and/or application software, or requires the removal of internal storage media, the contractor accepts the equipment “as is” and can elect at their own discretion to contract with the original equipment manufacturer (OEM) to restore the system.

s. Remote Monitoring, VA Network Connectivity, and Cloud Usage: Contractor shall identify whether system has remote monitoring capability. Systems with remote monitoring capability shall meet the following requirements to connect to the VA network and transmit patient and device data to a cloud for remote monitoring. Contractor shall be responsible for all costs associated with meeting the following requirements. Systems shall be capable of operating in stand-alone mode. Systems that do not meet the following requirements shall operate in stand-alone mode and shall not be allowed to connect to the VA network or transmit patient and device data until the following requirements are met.

Systems with remote monitoring capability shall be required to meet the following VA requirements within 12 months of contract award.

1) Shall meet VA Information and Information System Security and Privacy Requirements (Appendix C).

2) Shall be capable of bi-directional communication with VA’s electronic health care record systems (Cerner and cyberREN) (as applicable)

3) If Cloud services are required, shall connect to the VA Enterprise Cloud (VAEC) Amazon Web Services (AWS).

a) Contractor shall comply with the VA Authority to Operate (ATO) process.

b) System shall meet VA requirements as defined in VA Enterprise Cloud Technical Reference Guide, Version 1.3 July 2018 (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.asp x?DocumentId=4525852&FileName=36C10B18R2609-004.pdf) to use the VAEC.

c) System shall be FedRAMP authorized if Software-as-a-Service (SAS) or cloud service is provided. Contractor shall provide FedRAMP authorization documentation. NOTE: FedRAMP authorization is not required for systems using

VAEC.

1. The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA).

2. The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

3. Following guidance from the Federal Chief Information Officer (CIO), VA will utilize existing Joint Authorization Board (JAB) ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services.

4. The Contractor shall, where applicable, assist with the VA ATO Process to help achieve agency authorization of the cloud service or migrated application.

5. The Contractor shall complete a FedRAMP System Security Plan (SSP) and supporting documentation within 30 days after contract award.

6. The Contractor shall complete a Third-Party Assessment Organization (3PAO) Security Assessment Plan (SAP) within 75 days after contract award.

7. The Contractor shall complete a 3PAO Security Assessment Report (SAR) within 90 days after contract award.

8. The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

9. In order for live VA data to be used in this system, a FedRAMP Authorization and Agency ATO will be required.

https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4525852&FileName=36C10B18R2609-004.pdf https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4525852&FileName=36C10B18R2609-004.pdf https://www.fedramp.gov/agency-authorization/

10. Deliverables:

i. FedRAMP System Security Plan (SSP) and supporting documentation

ii. 3PAO Security Assessment Plan (SAP)

iii. 3PAO Security Assessment Report (SAR)

4) Shall utilize a supported operating system. Unsupported operating systems are those not supported by the manufacturer or have reached the end of lifecycle as published by the manufacturer (i.e. no further security patches will be released by the manufacturer nor will be available by other methods such as extended warranty purchases from the manufacturer).

5) If wireless network connection is required, shall meet FIPS 140-2 Certification.

Contractor shall provide FIPS certification status and certificate number.

6) Contractor shall provide VA access to the Contractor’s and Cloud Service Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

7) If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with Appendix C.

8) The Contractor Shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer’s Representative (COR)/Contracting Officer (CO).

9) Contractor shall work with VA Healthcare Technology Management (HTM)/Biomedical Engineering to provide the following documents/material in compliance with the VA Enterprise Risk Assessment (ERA) (cybersecurity risk assessment) process:

a) VA Form 6550 Appendix A (See SOW Appendix D) – Contractor shall provide in response to the RFP

b) Manufacturer Disclosure Statement for Medical Device Security (MDS2) – Contractor shall provide in response to the RFP

c) Ports, Protocols, and Services (PPS) document – Contractor shall provide during VA ERA after contract award

d) Software/Device Inventory document – Contractor shall provide during VA ERA Process after contract award

e) Data Flow Topological Diagram document – Contractor shall provide during VA ERA Process after contract award

t. Government Furnished Property: No Government Furnished Property shall be provided.

u. Disposal: Contractor shall be responsible for disposing of all old materials, supplies, and equipment.

v. Travel: Contractor shall be responsible for the cost of all travel.

w. Recalls: Contractor shall notify the VA National Center for Patient Safety (NCPS) Product Recall Office, Contracting Officer Representative (COR), and Contracting Officer (CO) within 24 hours of any FDA or manufacturer recall notices and patient safety alerts regarding systems provided under this contract. Notification shall be sent electronically to NCPS at VHANCPSRecalls@va.gov and HTM/Biomedical Engineering VHANCPSRMD@va.gov.

x. Protective Allocation: All systems, services, and consumables furnished via this contract shall be exempt from Contractor-imposed protective allocations and purchasing limitations.

y. Freight: The cost of freight shall be included in the system price and shall not be billed separately (FOB destination).

z. Packaging and Marking: Items shall be adequately packaged to prevent damage during shipping, handling, and storage. Delivered products and supplies shall contain the complete contract number, purchase order number, and shipping address. The contract number shall be provided upon award. The order number shall be provided by each VA site at the time the order is placed. A packing list/slip shall be enclosed with each shipment that includes the order number, items, unit of issue, items/quantity ordered, and items/quantity shipped. Packing list shall not be placed on box as to cover the product description or expiration dates.

aa. Shipping and Delivery: Unless otherwise specified, all orders shall be delivered complete within seven (7) calendar days after receipt of order. Emergency orders shall be delivered within 24-hours for CONUS and 48 hours for OCONUS locations after receipt of order. If an order cannot be delivered complete, or within the time frame arranged, the Contractor shall immediately notify the facility ordering official. Delivery may be rescheduled if determined by the ordering official that patient care will not be disrupted. It is the responsibility of the Contractor to comply with the decision of the ordering official.

The Contractor shall be responsible for delivery to the appropriate location in the U.S., Puerto Rico, Philippines and Guam specified by the ordering facility. This includes, but is not limited to, off-loading of delivery vehicle, and transporting/carriage to specific location (e.g. warehouse, office, room within a building/home, or other such site as directed). The Contractor shall provide the necessary means to accomplish such delivery; further, the Government shall not be required to accept shipment should the Contractor or his designee be unable to make delivery as required. The Government assumes no liability nor shall incur any costs for reshipment due to the Contractor’s or his designee’s failure to deliver due to the non-availability of the necessary delivery equipment as specified herein.

bb. Ordering Procedures: All orders shall be placed on an as needed basis, IAW the Ordering Guide. The Contractor shall not substitute any items and shall not increase or decrease mailto:VHANCPSRecalls@va.gov mailto:VHANCPSRMD@va.gov quantities ordered. Order numbers will be provided by each facility at the time the order is placed.

cc. Payment and Invoices (Purchased Systems, Services, and Consumables)

1) Invoicing: Contractor shall submit invoices monthly, in arrears, covering the services performed under this contract. Invoices shall be submitted to the address designated on each Delivery/Task Order. The invoice shall contain the following information:

contract number and purchase order number (if applicable), total price, services rendered, date of service, and contractor address

2) New Systems: Payment shall occur within 30 calendar days of VA receipt of Contractor system validation report unless abnormalities are identified by VA during baseline testing.

dd. Quarterly Sales Report: Contractor shall provide the CO and COR with a quarterly sales report (Excel format) via email that contains ordering site name, items ordered, and cost of order. Reports shall be provided within thirty (30) calendar days after the close of each quarter (1st Quarter: October 1–December 31, 2nd Quarter: January 1–March 31, 3rd Quarter: April 1–June 30, 4th Quarter: July 1–September 30)

4. ADDITIONAL REQUIREMENTS FOR LEASE/RENTAL SYSTEMS (FOR HOME USE):

The lease price shall be inclusive of all the requirements specified in Section 3.0 and Section 4.0. These items shall not be billed separately. All systems leased via this contract for home use, shall meet the requirements specified in Section 3. Additional requirements for leased systems for home use are as follows:

a. System Specific Requirements: Refer to Section 5.0.

1) Peritoneal dialysis systems

2) Home hemodialysis systems

3) Portable dialysis water purification systems

4) Portable integrated dialysis water and dialysate production systems

b. FDA Clearance: Shall have FDA clearance as a medical device for home dialysis.

c. Delivery: Contractor shall deliver systems and consumables (including dialysis solutions) to the ordering Medical Facility or Veterans home at the direction of the VA at the time of order placement.

d. Patient Education Materials: Contractor shall provide online portal available 24/7 with training materials for patients on system use and troubleshooting. Contractor shall provide patients with hard copy (PDF) of training materials as requested.

e. Device Replacement and Corrective Maintenance: For peritoneal dialysis systems, Contractor shall provide an exact loaner/replacement shipped directly to the VA site or patients’ home within one (1) business day following request for service and repairs by either VA or the patient. The Contractor shall provide their most current contact information to the VA center and the patient. Contact information shall be provided for 24/7/365, in the event VA or the patient need immediate resolution regarding repairs or maintenance.

f. Preventative Maintenance: Contractor shall perform all preventative maintenance services at the manufacturer required frequency.

g. Remote Monitoring and Connectivity: Device shall have remote monitoring capability including the ability for the VA provider to access data on device performance, treatment information, and prescriptions on-demand. Shall have ability to connect via either cellular or Wi-Fi. The vendor shall not be responsible for providing connectivity.

h. All-Inclusive Consumable Pack (priced separately, optional): VA shall have the option of purchasing a home dialysis consumable pack which shall include all consumables/disposables and dialysis solutions necessary for operation and maintenance of the home dialysis system. The cost of the all-inclusive consumable pack shall be priced separately.

i. Ordering and Payment: An ordering official shall place an individual Veteran specific task/purchase order for each home use situation. A task/purchase order for the equipment and installation will be faxed or emailed to the Contractor. Contractor shall acknowledge receipt of the task/purchase order, which will start the equipment order and installation procedure. Under no circumstances shall the Contractor begin production, shipping or installation without having a valid Veteran specific task/purchase order from an authorized ordering official. A Government Purchase Card is the preferred method of payment for home use orders. As a result, the Contractor shall accept the Government Purchase Card VISA Level II for payment and charge separately each Veteran specific order.

j. Invoicing: Contractor shall submit invoices monthly, in arrears, covering the services performed under this contract. A separate Veteran specific invoice shall be submitted back to the ordering official on each task/purchase order. The invoice shall contain the following information: patient name and address, contract number and purchase order number (if applicable), total price, services rendered, date of service, and contractor address. If Veteran is set-up in the middle of the month, the charges shall be prorated to only the days used in the month.

k. Equipment Removal: The lease cost of the equipment shall include removal of equipment from the Veteran’s home when it is no longer required.

5. SYSTEM SPECIFIC MINIMUM TECHNICAL REQUIREMENTS (MTR)

a. Central Dialysis Water Purification and Distribution System (In-Center, Purchased)

1) Standards: Shall have FDA clearance as a water purification system for hemodialysis

(21CFR876.5665).

2) Heat Disinfection: Shall be capable of fully automated heat disinfection of the entire system including the membranes and distribution loop. Shall not require chemical disinfection to meet AAMI standards.

3) Chemical, Microbial, and Endotoxin Contaminant Control: Shall provide product water to each dialysis station that meets the AAMI standards.

4) Sizing: Contractor shall provide the following sizing options:

a) Central Dialysis Water Purification and Distribution System for dialysis center with

1-12 stations

b) Central Dialysis Water Purification and Distribution System for dialysis center with 13-25 stations

c) Central Dialysis Water Purification and Distribution System for dialysis center with 26-38 stations

d) Central Dialysis Water Purification and Distribution System for dialysis center with 39-51 stations

5) Automation: Shall have full automation and monitoring of system functions and water quality including start, heat disinfection, safety features (divert, drain, shut down), back wash, and flush based on operator defined parameters.

6) Alarms: Shall have automated alarm system with visible and audible alarms in the water treatment room and patient treatment area that notifies operator when quality of water does not meet desired specifications or when system malfunctions.

7) User Interface: Shall have color touch control panel for all components and a remote color touch control panel at the nursing station.

8) Hemodialysis System Integration: Shall be compatible with all FDA 510(k) cleared hemodialysis systems.

9) Emergency Operation: Shall have capability for emergency single pass mode for each reverse osmosis (RO) membrane in the event of membrane or pump failure.

10) Design and Components:

a) Shall be a double (dual) pass stand-alone RO system.

b) Shall include all components for water purification including pre-treatment, purification, and distribution including devices, piping, fittings, and wall boxes to the point of use.

c) Shall have zero dead legs/space and maintain continuous flow throughout the entire system.

d) Piping, housings, and membranes shall be heat tolerant and chemically inert.

e) Shall include seismic restraints (as applicable).

f) Pre-Treatment System:

i. Pressure Gauges: Shall include pressure gauges before and after each component of the pre-treatment system.

ii. Sampling Ports: Shall include sampling ports before the first element in the system and after each element.

iii. Temperature Adjustment: Shall have temperature blending valve and properly sized water heater that meets AAMI specified temperature range for dialysis. Shall have a thermometer that displays output water temperature.

iv. Backflow Prevention: Shall have a backflow preventer valve.

v. Pressurization: Shall have booster pump with pressure switch that automatically turns booster pump on and off based on operator defined parameters.

vi. Grit and Sediment Filter: Shall have sediment filter with automatic backwash and programmable control head. Shall be capable of removing particulate matter to < 10 pounds per square inch (psi). Shall lockout RO when in backwash. Shall have a 7-day timer for display of the backwash cycle.

vii. Water Softener: Shall have automatic regeneration water softeners (2) and a brine tank. Softener shall be before the carbon tanks and have a lockout device to prevent regeneration during treatment. Shall provide softened water for a minimum of 2 days of operation before requiring regeneration.

Softener shall have a programmable control head for automated regeneration cycle setup and a 7-day timer for display of the regeneration cycle. Shall include pressure gauges on the water softener inlet and the outlet to measure pressure drops.

viii. Carbon Tanks: Shall have automatic backwashing carbon tanks and programable control head. Shall consist of a primary worker tank and a secondary polisher tank aligned in a series and are filled with pre-rinsed granular activated carbon. Tanks shall be sized to provide a minimum total Empty Bed Contact Time (EBCT) of 5 minutes per tank. Shall have sampling ports before and after the worker and polisher tanks. Tanks shall lockout RO when in backwash and shall have a programmable control head for automated backwash cycle setup and a 7-day timer for display of the backwash cycle. Shall have a continuous chlorine meter between the first and second carbon tanks and alarm at the nurse’s station.

ix. Bypass: Shall have bypass options for the temperature blending valve, sediment filter, and water softener tanks. Shall not bypass the carbon tanks.

x. Particulate Filter: Shall be after the secondary carbon tank and before the feed water inlet to the water purification system. Filter pore size shall be 1 micron.

g) Purification System:

i. Shall heat disinfect the entire water distribution system up to the dialysis station wall boxes (end to end disinfection). Shall have automated heating element control to maintain temperature that meets AAMI standards.

ii. RO Pump and Membranes: Shall have a high-pressure pump made of durable material that is capable of maintaining operating pressures per manufacturer guidelines. Shall have a RO membrane that meets AAMI standards for percentage rejection and conductivity of product water. Shall have built-in monitor to continuously measure percent rejection and conductivity of final product water and shall display in micro-Siemens per 1 cm or by the total dissolved solids in milligrams per liter or PPM. Shall have audible (able to be heard at dialysis unit treatment room(s) and nurses’ station) and visual alarms that notifies operator when quality of water does not meet desired specifications or when system malfunctions.

iii. Endotoxin Filter: Shall have a pore size of <0.05µ

h) Distribution Loop: Direct feed system preferred. Shall be sized to meet dialysis center size.

i) Post-Treatment: Shall include a water sampling port in the post-RO system.

b. Central Dialysis Water Purification and Distribution System Accessories (Separately

Priced) (In-Center, Purchased): Unit price shall include all corrective and preventive maintenance.

1) Emergency Deionization (DI) System: Shall include:

a) Shall provide emergency bypass in the event of RO system failure.

b) Shall include a minimum of two DI tanks connected in series (additional tanks may be requested based on center size) followed by an endotoxin filter system. DI system, couplings, and connecting tubing shall be leak free and meet AAMI standards. The capacity of the DI system shall be disclosed as volume of resin per tank and removal capacity per tank (as grains, CaCO3 equivalents).

c) Shall include a resistivity monitor and audible and visible resistivity meter alarms between the first and second tank including a remote audible alarm at the nurse’s station. Shall have a divert to drain function between the second tank and the distribution system that diverts water to drain in the event it does not meet AAMI

d) DI tanks shall be delivered in a semi-dry state (excess water removed), with inlet and outlet ports sealed with liquid-tight enclosures. Preservatives, germicides, or antifreeze solutions shall not be added. DI inlet and outlet connections shall be clearly labeled. DI tanks shall be labeled with date of regeneration, date of delivery to VA, and whether the tanks contain mixed bed, anion, or cation resin.

e) DI components shall be disinfected at time of resin regeneration. DI resin shall be kept separate from non-potable or non-medical applications. DI media shall be reagent grade (or better), consisting of strong base anion exchange resin and strong acid cation exchange resin. Industrial grade or “process” resin shall not be used.

2) Ultraviolet (UV) Disinfection System: Shall minimize bacterial growth using an approved germicidal radiation method.

3) Dialysis Wall Boxes: Contractor shall provide and install the dialysis wall station boxes (including feed lines to the dialysis machine) that connect the water distribution system to the hemodialysis machine model used by the VA center. Each box shall have a shut off valve and drain line. Installation shall be recessed into the wall cabinet or chase way. Shall provide the following wall box configuration options:

a) Dialysis wall station box with connections for water, acid, drain, dialysis machine

b) Dialysis wall station box with connections for water, bicarb, acid, drain, dialysis machine

c) Dialysis wall station box with two connections each for water, drain, dialysis machine

4) Temporary Central Water Purification and Distribution System (Monthly Lease with 24/7/365 service): Shall provide temporary product water to enable VA facilities to maintain operation. Shall have the following sizing options:

a) Temporary Dialysis Water Purification and Distribution System for dialysis center with 1-12 stations

b) Temporary Dialysis Water Purification and Distribution System for dialysis center with 13-25 stations

c) Temporary Dialysis Water Purification and Distribution System for dialysis center with 26-38 stations

d) Temporary Dialysis Water Purification and Distribution System for dialysis center with 39-51 stations

5) Chlorine Monitoring System

a) Shall automatically measure chlorine levels of pre-treatment water.

b) Shall be a component of the pre-treatment system and located between the first and second carbon tanks.

c) Shall include audible and visual alarms in the water treatment room and nurse’s station that notify operator when levels do not meet AAMI standards.

6) Digital Dialysate Conductivity Handheld Meter

a) Shall measure dialysate quality (conductivity, pH, and temperature) and water quality (conductivity, resistivity, temperature, pH, chlorine). Shall not require use of test strips.

b) Shall include carry case.

7) Point of Use Endotoxin Meter

a) Shall be a hand-held meter that provides real-time measurement of endotoxins to a sensitivity of at least 0.01 endotoxin units per mL.

c. Dialysate Delivery Systems (Separately Priced) (In-Center, Purchased)

1) Acid Distribution System: Shall have a tap to allow for manual drainage or filling acid jugs from the tank. Tubing shall be installed for each station. All system components and valves shall be permanently labeled with identification tags. Shall have the following sizing options:

a) Acid Distribution System for dialysis center with 1-12 stations

b) Acid Distribution System for dialysis center with 13-25 stations

c) Acid Distribution System for dialysis center with 26-38 stations

d) Acid Distribution System for dialysis center with 39-51 stations

2) Bicarbonate Mixing and Distribution System: Shall include bicarbonate sampling port.

Shall have the following sizing options:

a) Bicarbonate Mixing and Distribution System for dialysis center, 1-12 stations

b) Bicarbonate Mixing and Distribution System for dialysis center, 13-25 stations

c) Bicarbonate Mixing and Distribution System for dialysis center, 26-38 stations

d) Bicarbonate Mixing and Distribution System for dialysis center, 39-51 stations

d. Portable Dialysis Water Purification and Distribution System (In-Center, Purchased)

1) Standards: Shall have FDA clearance as a water purification system for hemodialysis and clearance for inpatient acute dialysis.

2) Heat Disinfection: Shall be capable of fully automated heat disinfection up to the hemodialysis system. Shall NOT require chemical disinfection to meet AAMI

3) Chemical, Microbial and Endotoxin Contaminant Control: Shall provide product water that meets AAMI standards.

4) Automation: Shall have full automation and built-in monitoring of system functions based on operator defined parameters.

5) Alarms: Shall have automated alarm system with visible and audible alarms that notifies operator when quality of water does not meet desired specifications or when system malfunctions.

6) Hemodialysis System Integration: Shall be compatible with all models of FDA cleared hemodialysis systems.

7) Design: Shall be compact portable unit that includes all components for water purification and provides continuous flow throughout the system. Shall be mobile or include a medical grade cart.

8) User Interface: Shall include a touchscreen control panel.

e. Portable Integrated Water Purification and Dialysate Production System (In-Center, Purchased)

1) Standards: Shall have FDA clearance as a high permeability hemodialysis system

(21CFR876.5860).

2) Therapies: Shall be capable of providing hemodialysis, sustained low efficiency dialysis (SLED), and ultrafiltration. Shall be capable of providing up to 24 hours of continuous therapy.

3) Dialysate Production: Shall be capable of producing dialysate from Environmental Protection Agency (EPA) quality potable water (i.e. tap water) that meets AAMI standards for dialysis.

4) Chemical, Microbial, and Endotoxin Contaminant Control: Shall produce product water and dialysate that meets AAMI requirements.

5) Automation: Shall have full automation of set-up, treatment management, and maintenance based on operator defined parameters.

6) Monitoring Treatment and Alarms: Shall have automated alarm system with visible and audible alarms that notifies operator when the system does not meet desired specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor blood flow (arterial and venous pressure, air detection, blood leaks, blood clots), fluid removal, ultrafiltration rate, water and dialysate quality (water pressure, temperature, conductivity, pH), supply and concentrate levels, and maintenance requirements.

7) Design: Shall include all components for water purification and dialysate delivery in one device. Shall be portable with lockable wheels.

8) User Interface: Shall include including a touchscreen control panel.

f. Hemodialysis System (In-Center, Purchased)

2) Therapies: Shall be capable of providing hemodialysis and ultrafiltration.

3) Chemical, Microbial, and Endotoxin Contaminant Control: Shall produce dialysate that meets AAMI requirements.

4) Dialysate Production and Delivery: Shall have options for use of dry bicarbonate powder or premixed liquid bicarbonate solution to make dialysate.

5) Automation: Shall have full automation of set-up, treatment management, and maintenance based on operator defined parameters including safety checks, auto start, auto prime, and auto heat disinfection.

6) Patient-Specific Treatment Parameters: Shall allow operator to set patient-specific treatment parameters including dialysate flow, UF goal, sodium profile, heparin dosing, blood pressure, blood pump speed.

7) Monitoring Treatment and Alarms: Shall have automated alarm system with visible and specifications or when system malfunctions. Alarms shall include a message and action required to correct condition. Shall automatically perform inviolable machine safety checks before each treatment. Shall have built-in sensors and alarms that monitor blood flow (arterial pressure, venous pressure, transmembrane pressure, venous needle dislodgement, air detection, blood leaks, blood clots, blood temperature, blood volume), fluid removal, ultrafiltration rate, access flow rate, water and dialysate quality (water pressure, temperature, conductivity, pH), supply and concentrate levels, and maintenance requirements.

8) Design: Shall include all components of the hemodialysis system in one portable device including blood pump and tubing, heparin pump and syringe holder pre filter and post-filter infusion ports, blood pressure sensors, blood pressure cuff, dialysate pump, bicarbonate connector, membrane, lockable wheels, manual hand crank.

9) User Interface: Shall include including a touchscreen control panel.

10) Water Connection: Shall be compatible with all FDA cleared water purification systems for hemodialysis. Shall include all hoses and connectors to enable connection of the hemodialysis system to the wall box. Shall have timers for auto start for integrated heat disinfection with the water purification system.

g. Hemodialysis System Accessories (Separately Priced):

1) Electronic Motorized Cart (In-Center, Purchased)

2) Monitors for real-time measurement of hematocrit, oxygen saturation, and/or fluid management (In-Center, Purchased)

3) Centrifuge Machine (Home Use, Rental)

h. Continuous / Extended Renal Replacement Therapy System (In-Center, Purchased)

2) Therapies: Shall be capable of providing Continuous / Extended Renal Replacement Therapy.

3) Automation: Shall have full automation of set-up, treatment management, and maintenance based on operator defined parameters including safety checks.

4) Patient-Specific Treatment Parameters: Shall allow operator to set patient-specific treatment parameters including dialysate flow, blood flow rate, pre and post filter solution flow rate, UF goal, heparin dosing, blood pump speed.

5) Monitoring Treatment and Alarms: Shall have automated alarm system with visible and specifications or when system malfunctions.