SOW Draft Tablo _ May 24.docx

STATEMENT OF WORK (SOW)

GENERAL GUIDANCE

1. Title of Project: Tablo Hemodialysis XT Device

2. Scope of Work: The purpose of this requirement is to obtain appropriate equipment for treating patients requiring renal replacement therapy. The contractor shall provide all labor, supervision and all other resources required to deliver the requirements stated herein, except as may otherwise be specified in this statement of work.

3. Background: Hemodialysis Units perform extracorporeal dialysis to replace the main activity of the kidneys in patients with impaired renal function. Impaired kidney function causes the body to retain metabolic wastes and water. Hemodialysis therapy removes these, as well as, ions and organic salts from the bloodstream. This process restores a reasonable state of health by partially performing renal functions, thereby minimizing further damage to other organs and physiologic systems. Extended renal replacement therapy is used to treat patients suffering from acute kidney injury (AKI), a critical condition characterized by sudden temporary loss of normal kidney function. VA Medical Center Birmingham requires a Tablo Hemodialysis XT device. This machine is used to provide hemodialysis to a patient in need of renal replacement therapy. It can be used in the Intensive Care setting, in patients’ rooms or in the dialysis unit in the acute care setting. The machine offers routine treatments for chronic patients up to extended treatments for critically ill patients. Tablo Hemodialysis XT will provide treatment duration for up to 24 hours.

4. Performance Period:. Installation and training will be completed within 30 days of delivery of the Tablo device.

5. Type of Contract: Firm-fixed price.

A. GENERAL REQUIREMENTS

The purpose of this requirement is to obtain the Outset Medical Tablo® Hemodialysis Systems, as medically appropriate, in an inpatient and/or outpatient VA healthcare setting. The Tablo device will require installation and training to be completed.

B. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

The contractor shall provide quantities specified:

1. Outset Medical Tablo® Hemodialysis XT Systems: The contractor shall provide one Tablo® Hemodialysis XT System.

2. Installation: The contractor shall provide installation for all systems purchased and confirm the device is mechanically operational prior to training.

3. Training: The contractor shall provide the different training options available so the sites can select the appropriate training option for their needs. This can include (but is not limited to) clinical/end user training/checklist.

C. EVALUATED OPTIONAL FEATURES: Not applicable D. SCHEDULE FOR DELIVERABLES: The contractor shall deliver the supplies ordered under this contract to the Birmingham Veteran Affairs Medical Center.

E. CHANGES TO THE STATEMENT OF WORK: No changes are expected.

F. REPORTING REQUIREMENTS: None required.

I. TRAVEL: Not applicable

J. GOVERNMENT RESPONSIBILITIES: The Government is responsible for communicating with the contractor promptly if assistance is needed in any matter related to this contract and for allowing reasonable time for contractor response and follow through.

K. CONTRACTOR EXPERIENCE REQUIREMENT: Not applicable.

L. CONFIDENTIALITY AND NONDISCLOSURE

1. 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.