ATTACHMENT E - UNIVERSAL REQUIREMENTS.pdf

1. 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/DocumentServ er.aspx?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.

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/

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.

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.

mailto:VHANCPSRecalls@va.gov mailto: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 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)