36C24720Q1081 – Combined Synopsis/Solicitation – 6515–544-20-3-126-0361/Fresenius Dialysis Machine Model #2008T/ (VA-20-00048081)

Aug 15, 2020 | SDVOSB Set-Asides

Statement of Work

Acquisition and Installation for Replacement Hemodialysis Units

REQUIREMENT:

This requirement is for a firm-fixed price for the acquisition and installation of sixteen (16) modern hemodialysis devices that are owned by the Dorn VA Medical Center, Columbia, SC utilized by the Hemodialysis unit. The existing 16 machines at the facility are reaching the end of their useful life and are needing to be replaced. This requirement shall include any installation and preparation work required, as well as any end-user training and service training for local technicians.

BACKGROUND:

The WJB Dorn VA Medical Center is a 216-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in Columbia, South Carolina and provides primary, secondary, and some tertiary care. Annually, the Medical Center serves approximately 56,116 patients. Satellite outpatient clinics are located in Anderson, Greenville, Florence, Orangeburg, Rock Hill, Sumter, and Spartanburg, South Carolina.

The Hemodialysis unit has ten (10) stations, with the capability of performing bedside dialysis in the ICU department along with portable RO systems. At least two machines are kept as standby at all times. On average the clinic sees about 55 patients per day over three shifts, and the clinic is open six days a week from Monday through Saturday. Sundays are utilized by the department for the central RO to heat disinfect the lines. This is a very high-demand clinic and all machines are used on a consistent basis. Due to their age and level of use the clinic is beginning to experience repeated periods of downtime on machines and it would be more economically feasible and more clinically reliable to replace the existing with new.

The EHR utilized at this facility is the cyberREN system and any new machine will need to be compatible with this system.

PERIOD OF PERFORMANCE:

This is a requirement for a one-time purchase and contractor installation services. This is being requested for installation as soon as parts are available and contractor is available for installation. Work shall be performed during normal business hours of 8:00am – 4:30pm Monday Friday, excluding Federal holidays. If extended hours are required by the contractor they must notify COR/ACOR and the owning department prior to scheduling the work.

The contractor shall make the best effort feasible to accomplish replacement of the dialysis machines while minimizing impact to the clinic and downtime due to the switchover. The contractor shall coordinate with the Hemodialysis clinic staff and Biomedical Engineering prior to scheduling any switchover.

PLACE OF PERFORMANCE:

Columbia VA Health Care System
6439 Garners Ferry Road
Columbia, SC 29209

The equipment is located in the main hospital Building 100, fifth floor. Please schedule with COR/ACOR prior to any service visits.

PERFORMANCE REQUIREMENTS:

A Contracting Officer Representative (COR) and/or Alternate Contracting Officer Representative (ACOR) shall be assigned to this procurement and written notification shall be provided to the Contractor after award.
Scheduling of work performance shall be arranged through the designated COR/ACOR assigned.

Contractor shall provide the following:
All personnel, parts, tools, test equipment, service manuals, firmware, system support and schematics necessary to provide and install sixteen (16) new hemodialysis machines and remove/dispose of the existing 16 already owned by the facility.
Planning, testing, and assurance that new machines meet quality standards and are ready for the clinic to use prior to initial cases commencing.
End-user training to ensure Hemodialysis clinic is familiarized with the new systems and are capable of performing treatments.
Service training for two (2) local technicians to be able to provide first look support for these systems.

The Contractor s service representative (CSR) shall contact the COR/ACOR to schedule delivery and installation of any equipment in order to coordinate space availability and interim workflows.

The Contractor shall be required to maintain compliance with facility Infection Control and Prevention measures, as determined by the level of work and dust generation that would be resultant from these replacements.

EXPERIENCE/CERTIFICATION
All work shall be performed by competent, experienced personnel qualified to work on the specified equipment in accordance with good manufacturing practices.

Contractor shall provide factory training certificates/competencies for personnel who shall be conducting post-install safety and compliance evaluations. Such certificates/competencies are to be submitted to COR/ACOR within 30 days from date of contract award. Failure to provide required documentation shall result in non-payment of invoices for this service.

Per ISO 9001, contractor shall list all the test equipment that had been used along with the details on the service report during any service associated with the medical equipment to include, but not limited to:
Test equipment name
Equipment Calibration due date
Model
Serial number
Manufacturer

REPORTS:
The Contractor s Service Representative shall present a comprehensive report following the conclusion of all installation and testing of new dialysis units. This report shall include:
Post-Installation evaluations with all required signatures
Minimum 4 hard copies of user manuals for distribution to end-users
Minimum 1 hard copy of service manual(s)
Maintenance requirements for periodic preventive maintenance and non-scheduled troubleshooting
Parts list of available user-serviceable parts, to include consumables.
Manufacturer s warranty information

Contractor shall provide the above documents to the COR/ACOR within 10 business days of completion of installation and testing activities.

SAFETY:
Contractor shall ensure all tools and equipment are secured at all times.
Tools and equipment must be removed from open areas or stored in secured location during breaks, lunch, and/or at the end of each work day.
All debris must be removed from the facility upon completion of service each day.

Operation of the equipment for testing, servicing, or any other purpose shall be done only in secured areas designated by the COR/ACOR and away from the general patient population.

Contractor shall ensure proper signage and/or blockage of service area is provided and clearly visible to ensure patient/employee safety is adhered to.
Smoking is not permitted within the facilities at any time. All smoking shall be conducted in designated smoking areas only.

INVOICES:

a. Payment shall be made monthly in arrears, invoices shall be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain:

Invoice Number and Date
Contractor s Name and Address
Accurate Purchase Order Number
Supply or Service provided
Period Supply or Service Provided
Total Amount Due

b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge.

c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:
       
Tungsten e-Invoice Setup Information: 1-877-489-6135
Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com
FSC e-Invoice Contact Information: 1-877-353-9791
FSC e-invoice email: vafsccshd@va.gov

Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

TERMINATION FOR CONVENIENCE: In accordance with FAR 52.212-4 (l) The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience.

RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:
The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:
Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.
Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.
Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.
Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.
Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.
The Government Agency owns the rights to all data/records produced as part of this contract.
The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.
Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].
No disposition of documents shall be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Columbia VAHCS Hemodialysis Machine Salient Characteristics:

The device must be a discreet device capable of performing standard hemodialysis treatment of patients via an arteriovenous (AV) fistula, AV graft, or vascular access catheter.
The device must be capable of performing Sustained Low Efficiency Dialysis (SLED)
The device must be capable of performing Low Volume treatments.
The device must be capable of utilizing both cartridge/bag and liquid solution for bicarbonate delivery.
The device must have an integrated operating system separate from the treatment controller system.
The device must be capable of continuously reporting on dialysis treatment quality, utilizing the following methods:
Device must be capable of utilizing the Kt/V method.
Device must be capable of utilizing Urea Reduction Ratio (URR) method.
The device must utilize an integrated blood temperature monitor (BTM).
The device must be capable of performing access flow monitoring for the monitoring of patient dialyzer access quality.
The device must be capable of interfacing and providing patient treatment data to the facility cyberREN Electronic Medical Record (EMR) system.
The device must be capable of accomplishing this interfacing without any additional/external equipment or components that are not standard with the device.
The device must have a wired ethernet/LAN connection for EMR connectivity.
Wireless connections will only be acceptable if they are FIPS 140-2 certified, with a current certificate provided by National Institutes of Standards and Technologies (NIST).
The device must have a keyboard that is an integrated component of the overall system.
The integrated keyboard must be a physical keyboard.
The integrated keyboard must be full-QWERTY with number pad.
The device must be capable of utilizing both centralized and portable Reverse Osmosis (R.O.) systems for supply water.
The device must utilize 120v / 60Hz standard electrical connection.
The device must have a maximum current draw of 15A or less.

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