Inactive

STATEMENT OF WORK Lithotripsy 1. General Description: The Contractor shall provide mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services and equipment (With related technical support) to the VA... STATEMENT OF WORK Lithotripsy 1. General Description: The Contractor shall provide mobile Extracorporeal Shock Wave Lithotripsy (ESWL) services and equipment (With related technical support) to the VASLCHCS at the George E. Wahlen VA Medical Center (VAMC), Salt Lake City, Utah. Scheduling will be in accordance with a regularly scheduled day on Tuesday and/or Thursday within the standard work hours of 8:00am to 4:30pm. According to mutually agreed upon procedures scheduled between the parties and as patient needs present for rare urgent cases within 72 hours. 2.  Administration: The services covered by this contract shall be furnished by the Contractor as defined herein. The Contractor will not be required to furnish such services on a national holiday or outside the standard work hours of 8:00am to 4:30pm. The estimated workload is 4 procedures per date of service with a range of approximately 1-6 cases as driven by patient care needs. The per procedure pricing shall single stone and multiple stone procedures per unilateral episode. The Contractor s technical personnel shall be certified and trained in ESWL services and operations of the unit(s). The Technician will assist the attending Urologist in the operation of the device. The technician may be required to operate the device and any related imaging equipment during procedures. The Contractor shall be responsible for providing the following A portable, state of the art, digital unit that can be easily moved in to the operating rooms Equipment will be in the operating room ready to treat patient at least 30 minutes prior to scheduled procedure Contractor shall wait at least 15 minutes after scheduled procedure time prior to proceeding to the next patient Equipment must meet or exceed the following criteria Treats all stones anywhere in the urinary tract Performs the fragmentation of renal stones using non-invasive techniques. The success rate shall be at least 80% Is modular and can treat patients in the operating room Has the ability to do endourologic procedures before and after ESWL without moving the patient Will accommodate patients up to 400 pounds The system must provide disintegration efficiency with results comparable to like systems using spark-gap technologies System must be capable of being employed with all anesthetic types including IV sedation, as well as no anesthesia The system must be capable of at least an average treatment rate of one patient per hour averaged over an eight-hour period. Documentation to support this capacity must be provided with the proposal for evaluation Is available for pro re nata (PRN) (as needed) services Contractor shall provide such additional materials and supplies, including consumables as are necessary to conduct ESWL procedures with the Unit(s) Contractor shall provide maintenance of the device to include service and preventative maintenance to insure that the device unequivocally performs/operates at a level equal to the equipment manufacturer s original specifications. Preventative maintenance documents for Contractor equipment shall be available to the VAMC Biomedical Engineering staff upon request. All equipment is required to be safety checked by Biomedical Engineering staff each time it arrives on site before any procedures begin Contractor shall be responsible for obtaining all necessary licenses, approvals, and permits and be in compliance with all federal, state, and local laws and regulations applicable to the device and delivery of ESWL related services provide for under the terms of this contract The contractor equipment must not be connected to a VA computer network. Personally Identifiable Information (PII) including but not limited to name, date of birth and social security number must not be entered into the equipment at any time for any purpose. Contractor shall deliver all reports, digital, film and file records of all procedures performed with the device to the OR staff at the conclusion of treatment on the scheduled visit for all of the day s lithotripsy patients. These medical records shall be the property of the VAMC or any related facility within the Veteran s Health Administration (VHA) where the patient receives care Contractor shall perform all services under this agreement in accordance with any and all regulatory and accreditation standards applicable to facility, including without limitations, those requirements imposed by Joint Commission (JC). Contractor shall provide consultation, if requested, in the development of protocols, utilization review, peer review and risk management as required by JC and other regulatory bodies Contractor shall perform services within the policies, procedures and regulations (such as the medical staff by-laws and professional standards board) governing the VAMC or any related facility within the VHA where the patient receives care The VAMC will provide the following: Suitable electric service to operate the Unit(s) A secure room for the device while located on the premises (Operating Suite) Scheduling of patients for the unit and scheduling of in-service relating to the device for facility staff Pre-operative preparation of patients for ESWL, written patient consent forms and necessary services relating to post-operative recovery. The VAMC shall be responsible for providing physicians, facilities and supplies necessary to provide patients with emergency medical care as may be required, as well as physicians, facilities and supplies necessary to provide patients with inpatient or outpatient post-procedure care Taking all actions reasonably necessary to assist Contractor in achieving compliance with federal, state and local laws and regulations Equipment safety check prior to initial use on each visit The collection and disposal of infectious waste and sharps related to the ESWL procedures Retreatment and Cancellation If a veteran must undergo an additional treatment within ninety (90) days with his/her initial procedure due to continued problems with the stone(s) and at no fault of the contractor, i.e. stone(s) was not broken down small enough to pass or fragments of the stones remain, the Contractor shall provide the additional treatment at 50% of the contract price In the event the scheduled procedure needs to be cancelled; This may occur (1) when a stone passes between the time the patient was initially seen and scheduled and the actual procedure date or (2) when there is a medical emergency such as when anesthesia is administered or another medical emergency with the patient arises The Contractor shall not charge any amount for technical failures that occur during treatment or that prohibit treatment Contractor shall provide the same professional level of care to VAMC patients and/or beneficiaries as to any other patient under his/her care. Contractor shall provide all services specified in this contract for any person for whom such services are ordered. The Contractor further warrants that he/she shall not subcontract any portion of these services Organizational Relationship: Contract staff is responsible for responding to guidance given by the Chief, Surgical Service Qualifications: Contractor shall provide technical personnel certified and trained in EWSL services and operation of the unit(s) Personnel assigned by the Contractor to perform the services covered by this contract shall be licensed in the State of Utah. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and the Chief of Urology Section All Continuing Education requirements shall be met to maintain professional status. A staffing plan, to include back-up coverage, position description, and competency assessment tools shall be provided to the Contracting Officer Representative (COR) within fifteen (15) calendar days after award. The staffing plan shall be approved by the VAMC prior to commencement of patient care activities. All related documentation, such as completed competency checklists or education training records, shall be maintained by the Contractor and the VAMC. Contractor s employee(s) shall be United States citizens and shall be technically proficient in the skills necessary to fulfill the Government s requirements, to include the ability to speak, understand, read and write English fluently Quality Assurance Monitoring of the Contractor s performance shall be demonstrated as referenced in the Quality Assurance Surveillance Plan (QASP) and verification of patient records that the specified services were performed. The Contractor shall be required to sign an attendance log upon reporting for scheduled procedures and upon completion of the procedures. The COR shall be the VA official responsible for verifying contract compliance. Any incidents of Contractor non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer ID Badges/Parking/Smoking Policy All contractor personnel are required to wear VA-issued identification (ID) badges during the time that they are on the VA grounds It is the responsibility of the Contractor personnel to park only in designated parking areas. Parking information is available from Surgery Service or the VA Police Smoking is not permitted within or around the VAMC facilities, except in designated areas 7. Delivery Location: VA Salt Lake City Healthcare System Operating Room (OR) Building 14, 3rd Floor, Room 3B22 500 Foothill Drive Salt Lake City, UT 84148 Deliveries will be made Tuesday and Thursday (excluding holidays which are listed below) between the hours of 8:00 AM and 4:30pm PM. Federal Holidays are as follows and include any other days specifically declared by the President Of the United States to be deemed a holiday. New Year s Day Martin Luther King s Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas 8. Delivery Commitment: Time of delivery specified or mutually agreed to at the time of receipt of telephone order shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. 9. Person Authorized to Place Orders: In addition to the Contracting Officer, the COR is authorized to place orders under this contract, as well as any Nuclear Medicine Technologist employed by the VA Hospital. 10. The services specified herein may be changed by bi-lateral written modification. The modification will be prepared by the VA Contracting Officer.