P09 - PWS Full Service Contract for Dialysis Units.pdf

Outset Tablo Dialysis Unit Full Service Contract

Project

Full Service Contract for Dialysis Units

Period of Performance

FY2021

Background

The VA Northern California Health Care System (VANCHCS) is in need for a full-service contract for our Outset Tablo dialysis units at Mather, CA and Martinez, CA. This full service contract includes repairs, corrective and preventative maintenance, and replacement original equipment manufacturer (OEM) parts serviced by a vendor certified by the OEM.

System Requirements

Contractor shall provide the following service:

Item Part Number Description Quantity 1 OMSVC Annual Tablo Product and Program Support ("Service")

For Tablo Units: 400741, 400744, 400745, 400924, 400941, 400942 (qty: 6 units)

Schedule

This is for a base year plus four option year requirement.

Date of Award 2021 to 2022

Option Year 1 2022 to 2023

Option Year 2 2023 to 2024

Option Year 3 2024 to 2025

Option Year 4 2025 to 2026

Technical Requirements

Solution shall have the following requirements:

- The Contractor will come on-site and provide one (1) annual preventative maintenance per unit.

o Contractor shall perform Preventive Maintenance inspections yearly as requested.

o Preventative Maintenance including PM required parts, system verification, alignment, and adjustments are provided by the Contractor at no additional customer cost during the hours of coverage. Factory-trained and authorized service labor and travel required for PM are included at no additional customer cost during the hours of coverage.

o Technical support via phone, email, and web is provided.

o Priority service scheduling is included.

o Reliability updates are included.

o Certified OEM replacement parts are included.

o The Contractor shall furnish documentation such as equipment verification, including all measurement and calibration data to certify that the system is performing in accordance with the performance specifications.

- The Contractor will provide on‐site service calls in order to make necessary repairs and adjustments to the equipment.

o All required parts shall be furnished, with the exception of expendable, consumable. Pricing shall be at exchange price from the Contractor or one of their subsidiaries. Consumable and expendable parts are defined as items that require replacement on a greater than one-month frequency. Any exceptions shall be noted by the Contractor in writing prior to the initiation of the contract. All subsequent decisions on classification of parts are at the discretion of the Biomedical Engineer.

o Unscheduled, Emergency Service including parts, system verification, alignment, and adjustments are provided by the Contractor at no additional customer cost during the hours of coverage. Factory-trained and authorized service labor and travel required for unscheduled, emergency maintenance are included at no additional customer cost during the hours of coverage.

o The CO, COR or designated alternate has the authority to approve/request a service call from the Contractor.

- The Contractor will provide and install equipment software updates as needed.

- PHONE SUPPORT: The Contractor will have 24x7 live phone support via 844‐MYTABLO.

- TABLOHUB: Access to web portal for monitoring device health and performance and viewing flow sheets and service logs. Access to TabloHub requires device connectivity.

- Include at least 5 Designated Support Contacts from the vendor.

- Include at least 1 Designated RMA Contacts from the vendor.

- Include POC for Technical Support Engineer.

- Troubleshoot all components and peripherals of the dialysis workflow; equipment, tubing, water system, filters.

- The Contractor shall furnish and replace standard parts at no cost. The Contractor shall have ready access to all replacement parts. All parts supplied shall be the original equipment manufacturer (OEM) or OEM certified which are fully compatible with existing equipment. The contract shall include all parts with the exception of consumable or expendable items. The Contractor shall use new parts.

- Expedited shipping on parts, equipment and etc…

- Vendor will provide at least 8 OEM carbon filters and at least 4 OEM sediment filters.

Standards Requirements

- Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, Federal and VA specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

- The Contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard.

o The Contractor shall:

A. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

B. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

C. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

- Meets AAMI water standards.

- Contractor will provide specific water requirements for equipment source water quality.

- Contractor to perform annual water assessment audits.

Security Requirements

The C&A requirements do not apply, and that a Security Accreditation Package is not required.

Warranty

Contractor shall provide one (1) year of ongoing support and warranty after complete installation of the equipment.

All labor, time, materials, equipment, travel, service manuals and supplies necessary to keep equipment operational during the warranty period shall be included. Phone response to warranty issues within 1 hour and on-site response within 24-hours is required.

The Contracting Officer Representative (COR) shall monitor performance through routine inspections and maintain copies of all service records. Any issues will be brought up to Contractor’s service manager.

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

On-Site Service

Contractor shall service the equipment at the VA Northern California Health Care System.

Contractor shall verify full functionality of the solution with VANCHCS before stating that service has been completed.

Contractor shall coordinate service during normal business hours, all onsite visits will be performed during the normal VANCHCS business hours (8:00 a.m. - 4:30 p.m.) Monday through Friday, except Federal holidays, unless otherwise specified. The Contractor may work outside normal business hours by arrangement with the COR if such services are provided without additional charge to the Government. Any overtime charges must be approved by the COR prior to the initiation of overtime work.

Documentation/Reports

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

A. Name of Contractor

B. Name of FSE who performed services.

C. Contractor Service ESR Number/Log Number.

D. Date, Time (starting and ending), Hours-On-Site for service call.

E. Description of Problem Reported by COR/User.

F. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

G. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

H. Total Cost to be billed.

I. Signatures from the following:

1. FSE performing services described.

2. VA Employee who witnessed service described.

J. Equipment downtime, calculated in accordance with Conformance Standards.

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS

COMPLETED!

Reporting Requirements

The Contractor shall report to Biomedical Engineering to "check-in" upon arrival and prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact.

When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s). The FSE shall be required to check out with the Biomedical Engineering Department (location to be specified at time of contract award) and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COTR within 5 business days of work completion.

FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR

REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND

MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT.

Additional Charges

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

Reporting Required Services Beyond the Contract Scope

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

Condition of Equipment

The Contractor accepts responsibility for the equipment described in Section B, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

Competency of Personnel Servicing Equipment

A. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified in Section B. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment identified in Section B.

C. The FSE(s) shall be authorized by the Contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC. The CO may authenticate the training requirements, request copies of training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or the COR specifically reserve the right to reject any of the Contractor’s personnel and refuse them permission to work on the VAMC equipment.

Competency of Personal Servicing Equipment

“Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified items in this document.

For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment identified in this document.

The FSE(s) shall be authorized by the Contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC. The CO may authenticate the training requirements, request copies of training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or the COR specifically reserve the right to reject any of the Contractor’s personnel and refuse them permission to work on the VAMC equipment.

Training

Contractor shall provide necessary training, user manuals and ensure competency on operation and maintenance for the equipment. Contractor shall provide clinical and technical support if additional assistance is needed. Training will be given on replacing filters.

Place of Performance

The selected vendor shall service equipment at the VA Northern California Health Care System.

The address of VANCHCS is 10535 Hospital Way, Mather, CA 95655.

And at the Martinez Clinic location at 150 Muir Rd. Martinez, CA 94553.

All onsite visits will be performed during the normal VANCHCS business hours (8:00 a.m. - 4:30 p.m.)

Monday through Friday, except Federal holidays, unless otherwise specified. The Contractor may work outside normal business hours by arrangement with the COR if such services are provided without additional charge to the Government. Any overtime charges must be approved by the COR prior to the initiation of overtime work.

Delivery

The selected vendor shall deliver any equipment or parts to VANCHCS, located at 10535 Hospital Way, Mather, CA 95655. And at the Martinez Clinic location at 150 Muir Rd. Martinez, CA 94553.

Identification, Parking, Smoking, Cellular Phone Use and VA Regulations

The Contractor shall wear visible identification at all times while on the premises onsite. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VANCHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the onsite. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search.

Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

Other Pertinent Information or Special Considerations The Contractor must follow all HIPA rules, regulations and restrictions regarding disclosure of any personal identifying information observed during the service of the equipment.

Contractors must abide by VA policy, including policies under special circumstances such as the COVID 19 pandemic to include mandatory masking, social distancing and screening upon entry.

References

Definitions/Acronyms

A. Biomedical Engineering – Supervisor or designee, Phone Number (916) 843-2875.

B. CO – Contracting Officer.

C. COR – Contracting Officer's Representative.

D. PM – Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

E. FSE - Field Service Engineer – A person who is authorized by the Contractor to perform maintenance (corrective and/or preventive) services on the VA campus.

F. ESR - Vendor Engineering Service Report –A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

G. Acceptance Signature – VA employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

H. Authorization Signature – COR's signature; indicates COR accepts work status as stated in ESR.

I. NFPA – National Fire Protection Association.

J. CDRH – Center for Devices and Radiological Health.

K. VAMC – Department of Veterans Affairs Medical Center

L. OEM – Original Equipment Manufacturer

M. TJC – The Joint Commission

O. OSHA – Occupational Safety and Health Administration