Statement_of_Work.docx

Statement of Work

COR : David Ram

Project Officer: Kathleen Krisko (Alternate)

Period of Performance: Base Year August 1, 2018-July 31, 2019 + (3) option periods Background

The National Institutes of Health (NIH) Clinical Center is a 200 bed tertiary care research hospital in Bethesda, Maryland. The hospital is part of the National Institutes of Health, a federal government agency under the Department of Health and Human Services. The Materials Management and Environment Services Department (MMESD) is responsible for the acquisition of supplies, inventory management, biomedical equipment repair, installation and maintenance and storage and distribution of materials for the hospital. In addition, the department provides specialized housekeeping operations that meet nationally recognized infection prevention, occupational and environmental safety guidelines and standards. Among these are the U.S. OSHA and The Joint Commission, the hospital accreditation agency.

The Biomedical Engineering and Property Management Section manages the inspection, testing, repairs, calibration, safety, and performance monitoring of clinical and nonclinical equipment and ensures all clinical equipment meets regulatory agency(s) regulations and industry standards. The section works closely with the Standardization Committee and other pertinent Clinical Center committees in forecasting, planning, and integrating current and future clinical equipment requirements for researchers.

MMESD currently uses (3) Medivator Automated Endoscope Preprocessors (AER). The Automated Endoscope Re-processors (AERs) are devices used in the Central Sterile Processing section of the NIH Clinical Center to reprocess endoscopes, such as duodeno scopes, and endoscope accessories, to decontaminate them between uses. AERs are designed to kill microorganisms in or on reusable endoscopes by exposing their outside surfaces and interior channels to chemical solutions. AERs are Class II devices.

Due to the potential association between reprocessed scopes and patient infection, the FDA initially requested validation testing data from all companies that have AERs labeled to reprocess. In this request, AER manufacturers conducted additional rigorous validation testing with scopes to evaluate AER reprocessing effectiveness of the recess around the scope’s elevator area. To support adequate high level disinfection or liquid chemical sterilization, testing should demonstrate a 99.9999 percent reduction of the most resistant microbes at several locations on the scope to prevent infection transmission.

In June 2017, the FDA determined that it is necessary for manufacturers of certain reusable medical devices (including AERs) to include in their premarket notification (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be used. FDA published this list in accordance with the requirements established by the 21st Century Cures Act. These actions were effective on August 8, 2017.

In addition, given scopes’ complex design and rigorous manual cleaning instructions, the FDA recommends that the AER cleaning cycle only be used as a supplement to thorough manual cleaning according to the scope manufacturer’s instructions and that all maintenance and repair be performed by the manufacturer (see attached letter from Medivators). Therefore Medivators is the only source for this requirement.

Purpose

MMESD has a requirement to procure annual quarterly maintenance for the following equipment:

The vendor will include in this maintenance agreement the following:

· All services (maintenance and repairs) must be made by a Medivator field engineer and/or technician.

· Annual on-site quarterly inspection and preventative maintenance on the machines in accordance with Medivators current Preventative Maintenance Checklist (PMCL). This includes replacement parts that are included in the Medivators standard preventative maintenance kit. The contractor will schedule maintenance visits in cooperation with the department at mutually convenient times and places during normal working hours (8:00 A.M.-4:00 P.M. Monday - Friday, excluding holidays).

· Inspections: Before and after completion of the maintenance described herein, the contractor shall document the service performed and notify the unit coordinator and BIOMED.

· Repairs on machines listed. This includes labor, travel, parts and any shipping costs for parts. Availability for repairs after hours and on weekends is required. Contractor will provide unplanned service response with-in 4 hours of being contacted. On-site service will be provided within 24-hours, excluding holidays, upon notification by the department point of contact.

· Contractor will provide unlimited access to technical telephone support from Technical Service team (Unlimited telephone support including weekends and evening shifts until 10:00pm.

· Annual training recertification for staff at a time convenient for the servicing department.

Minimum Standards of Workmanship:

All work shall be performed in compliance with all Federal, State and Local Laws and Regulations. In addition, work will meet equipment’s manufacturer and generally accepted industry standards of good workmanship. All waste materials shall be disposed of by the contractor in compliance with Federal State and Local laws and regulations.

Point of Contact: David Ram – Phone: 301-496-1311, Fax: 301-402-0049 National Institutes of Health, Clinical Center Materials Management, Biomedical Engineering

Invoice Requirements: The vendor will submit an invoice with the following information:

Invoice submitted concurrently as follows:

a. Original to the following designated payment office: National Institutes of Health, Commercial Accounts, 2115 East Jefferson St. Ste. 4B-432, Bethesda, MD 20892

b. One copy to the Materials Management Department: Faxed to David Ram. Fax: 301-402-0049