J--Surgical Instrument Service
Page 7 of 7 PERFORMANCE OF WORK STATEMENT FOR INSTRUMENT PREVENTATIVE MAINTENANCE Medical Centers covered: The medical center covered by this performance work statement: VAMC Manchester, NH 718 Smyth ... Page 7 of 7 PERFORMANCE OF WORK STATEMENT FOR INSTRUMENT PREVENTATIVE MAINTENANCE Medical Centers covered: The medical center covered by this performance work statement: VAMC Manchester, NH 718 Smyth Road Manchester, NH 03104 Ph. (603) 624-4366 Scope of Work: The period of this contract shall include one base year plus four option years. The Contractor shall provide all parts and materials, labor, and travel related expenses for all surgical instrument inspection, maintenance, and/or cleaning for all types of government-owned powered and non-powered surgical instrumentation regardless of manufacturer. The Contractor will provide all personnel, equipment, tools, materials, supervision, technical literature, manufacturer repair requirements and manuals, transportation and other items and services necessary to provide a Surgical Instrument Maintenance Program as defined in this PWS. The Contractor will provide support consistent with the policies and standards of the customer and its governing authority. The Contractor will always restore and adhere to putting the passivation layer back onto all instruments. The Contractor will provide support in the following areas: On-site Preventative Maintenance Services Preventive Maintenance shall include one annual assessment/repair to all instruments or devices covered by this contract. The Contractor shall determine frequency of scheduled maintenance service with SPS Chief or designee based on frequency of use. The estimated quantities of work shall be determined by Contractor repair technician and SPS Chief or designee. Examples include, but are not limited to inspections, sharpening, adjusting, passivation, full restoration, and refurbishments of all instrument sets and components listed in Appendix A of this document. The Contractor shall identify instruments that are defective and that show excessive wear and tear. Instruments shall be clearly marked and labeled with description of the problem. Conformance Standards: All services provided under this contract must be performed in conformance with the American National Standards Institute (ANSI) and the Advancement of Medical Instrumentation (AAMI). ANSI-AAMI ST-59 Part 1: (General Sterilization of Health Care Products), ANSI-AAMI ST-79 Part 7.7: (Servicing and Repairs of Devices in the Health Care Facility), Center for Disease Control (CDC) regulations, International Association of Healthcare Central Service Material Management (IAHCSMM) standards, Association for Professionals in Infection Control and Epidemiology (APIC), National Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA), and Original Equipment Manufacturer standards and specifications. Hours of Work: Hours of work for maintenance are defined as Monday through Friday from 7:00 a.m. to 4:00 p.m., excluding federal holidays or as otherwise arranged with the Contracting Officer s Representative (COR). The Contractor shall notify the COR of the existence or development of any defects in, or repairs to the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse). Specific Mandatory Tasks and Associated Deliverables: The Contractor shall provide scheduled preventive maintenance on all surgical instruments once per year. For this purpose all instruments shall be provided to the contractor on a schedule to be determined by the SPS department in conjunction with the contractor. For this purpose and regular repair purposes the contractor shall be on site a minimum of once per month. Monthly on site visits shall be coordinated with Clinical Engineering and the SPS departments. Instruments and instrument sets are to be retrieved from the Sterile Processing Service (SPS) and returned once maintenance and sharpening is completed on the same day. The contractor will provide on-location maintenance/sharpening services. SPS may prioritize instruments, sets, and power tool maintenance based on operating room needs and scheduled surgical procedures. All single instruments and instrument sets picked up/delivered by the contractor shall be properly listed for accountability verification. The contractor shall tag instruments with the appropriate labels (not etching) to identify instrument maintenance inspection date. The contractor shall passivate instruments to maximize life expectancy of the instruments. The contractor shall perform an on-site inspection of all surgical instrumentation covered in this service contract. Based on the results of the on-site inspection, the contractor will provide advice to the SPS on ways to improve processes, reduce maintenance costs and provide a recommended maintenance schedule. The contractor must send personnel qualified to inspect and maintain instrumentation for as specified number of visits per year. The contractor shall test instruments for accurate alignment, sharpness, insulation, and calibration. If the instrument needs to be repaired beyond the scope of the contract, the contractor shall notify the VAMC SPS Chief, Clinical Engineering, or their designees. Maintenance of surgical instruments shall be performed in accordance with manufacturer requirements. The contractor will be responsible for initial set up and then, upon completion of services, is responsible for clean-up of all areas where maintenance and sharpening services have been performed. The contractor will inspect, mark, and remove all unserviceable surgical instruments. Every instrument that is defective shall be clearly marked with a description of the problem and be removed from service to avoid any potential injury. The SPS Chief or designee will determine if permanent removal of the instrument is necessary based on instrument inspection and contractor recommendation. When required and supplied by the facility, the contractor staff will wear special protective clothing and shoe covers. When duties will be performed in specified areas, a disposable protective hood shall be worn to ensure infection control standards are met. These items shall remain the property of the VAMC and shall not be removed from the facility. After use, protective clothing shall be turned in or destroyed as directed by the SPS Chief. The contractor shall maintain open and professional communication with members of the VAMC staff. Contractor issues will first be addressed by appropriate facility personnel and brought to the attention of the contracting officer and the contractor representative for resolution. Check in Requirements: The Field Service Engineer must report to the Clinical Engineering. Submit any mobile media devices that would be used on the system to a virus scan to Clinical Engineering. Upon completion of work, the Field Service Engineer must report to Clinical Engineering to sign out and brief Clinical Engineering Staff or Supervisor if Clinical Engineering Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will return the badge and sign out in the Clinical Engineering Department. Clinical Engineering can be reached at; Manchester VAMC (603) 624-4366 x6141 Parts: The Contractor shall furnish all parts as necessary to maintain the equipment, covered by this contract, in accordance with the Conformance Standards Section. The Contractor stipulates that he/she has ready access to new standard parts (manufactured, supplied by the manufacturer, or equal thereto). All parts supplied shall be of current manufacturer and have full compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request. Documentation/Reports: The Contractor shall submit a legible field service report, which shall include detailed descriptions of the inspection and maintenance services performed, including date of maintenance, instrument type, and replaced parts. NOTE: Any additional charges to be claimed must have been approved by the COR before service was performed. Competency of Personnel Servicing Equipment: The Contractor s staff shall include a fully qualified Field Service Representative assigned to this area and a fully qualified Field Service Representative who shall serve as the backup. Fully qualified is based upon training and on experience in the field. For training, the Field Service Representatives must have successfully completed a formalized training program for the equipment covered under this contract. For field experience, the Field Service Engineers must have a minimum of one (1) year of experience providing preventive maintenance and emergency repair services on the same make and model of equipment covered under this contract. All Contractor staff shall be certified in blood borne pathogens and operating room protocol. Test Equipment: Upon request of the COR or the Contracting Officer, the Contractor shall provide a copy of the current Calibration Certification of all test equipment which is to be used by the Contractor to perform service under this contract. Calibration of equipment shall be traceable and in conformance with test equipment Original Equipment Manufacturer standards. Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer or COR may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served on the Contractor or his representative at the work site, shall be deemed sufficient for corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work, and hold the Contractor in default. Appendix A Site Specific Surgical Instruments Each listing is meant to describe a minimum of instruments serviced under this contract. Other instruments and medical devices may be added to the listing on an Ad Hoc basis as determined by the Contracting Officer and/or the COR. Instrument and Device List for Manchester VAMC Operating Room Instruments Dental Instruments Podiatry Instruments Lens and sheath arthroscopy set Micro mini 5 curette sets Large nail clippers Olympus and wolf stopcocks Heat instrument sets Small nail clippers Accufex Arthroscopic Instrument set Root planing kit Tissue nippers Arthrex Shoulder punch set Polishing and adjustment kits Nail and bone files Screw removal instrument set Blue cam sheath Bone files Urology and Ortho cameras Kavo handpieces Curettes Advantage Turbo shave Midwest handpieces Probes Cordless driver RDH handpieces Bone and nail rasps Zimmer drill bits Blis Sonic handpieces and accessories #3 knife handle Van Buren sounds Low speed motors and accessories Beaver handle Prostrate probe Piezo handpieces Probe Mitex VAPR cord Surgical handpieces One point scissor Express sew suture passer Aseptico motor and handpiece Mayo scissor Bougies A Titan forceps Bandage scissor Clip appliers Apex locators Iris scissor Basin sets Arestin syringes Kelly clamp Capsule pliers Straight & curved crille Kits: Composite gun Small instrument sets Bite blocks Eye Instruments Medium instrument sets Crown & bridge remover Nail and wart sets Curing lights Bur Hand surgery sets Elevators Chalezion forceps Large instrument sets Excruder dispenser Castro scissors Hemorrhoid instrument sets HVE and SE valves Tenotomy scissor Master shoulder sets Implant scalers Iris scissor Retractor sets Impression trays Golf instruments D&C instrument sets Mandrells Lacrimal dilstor Open Shoulder instrument sets Oraqix dispensers Punctual gauge ENT Instruments Plastic protectors Tweezers and forceps RINN rings and rods Mosquito Rubber dam punch Strabismus hook Sharpening stones Tenotomy scissor System B tips Bayonet forceps Hollenback plugger Curette Ear hook Kits: Ear speculum Amalgam sets Suctions Crown and Bridge sets Mirrors Endo sets Syringe Exam kits Prophy kits Women s Health Oral surgery kits Perio surgery sets Tischler forceps Apioectomy set Mayo scissor Biopsy kits Metz scissor Bandage Derm Instruments Bozeman forceps Cervical dilators Hyfrecator Kavorkian curette Suture sets Graves and Pederson vag speculums Suture removal sets Polyp forceps Bandage scissor Sponge sticks Comedone extractor Uterine sounds
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