Olympus Scope Repair

Performance Work Statement (PWS) For Repair of Multiple Endoscopes Medical Treatment Facility, David Grant Medical Center Travis AFB 19 Jan 15 Table of Contents SECTION NO. AND TITLE PAGE NO. I. Description of Service 3 II. General Information 4 III. Appendices 6 A. Applicable Publications and Forms 6 B. Equipment List 8 PERFORMANCE WORK STAEMENT (PWS) Medical Treatment Facility, David Grant Medical Center Travis AFB I. Description of Services 1. The objective of this contract is to provide clinical departments at David Grant Medical Center with all management, tools, parts materials (including all items listed in the attached Appendix II, Delivery Schedule for David Grant Medical Center, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to install the instrumentation described in the attached Appendix A, Technical Requirements for David Grant Medical Center Travis AFB. Services include one-time intervening repair service requirements. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices. Repair technicians must be certified by the Original Equipment Manufacturer (OEM) to perform all necessary maintenance and or repair. All parts and supplies must be manufactured and certified by the OEM as well as carry the equivalent warranties. Documentation, verifying repair technicians are OEM certified and that only OEM parts will be used, must be provided to the contracting officer within 30 days of award. All services must be performed according to OEM procedures and be guaranteed to the same extent as provided by the OEM. 1.1 Pre-Market Approval. Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation. 1.2 Service Reporting. Contractor shall furnish a legible service report to the Medical Equipment Repair Center (MERC) personnel including the date, time, company name and service representative, contract number, description of malfunction, description of any services performed, and any recommendations necessary to maintain equipment in the best operating condition. II. General Information 1. Government Furnished Property The government will provide the following equipment, supplies and services listed below: 1.1. Utilities: For the purpose of this contract, the government will furnish all required utilities such as water, telephone, electricity, etc.). Long distance and Defense Switched Network (DSN) telephone services will be provided for official use only. 1.2. Housekeeping: Housekeeping services will be provided by the MTF. 1.3. Security Forces and Fire Protection: Phone numbers: Non-Emergency Fire Department: 424-3683; Non-Emergency Security Police: 424-3293. Emergencies: 424-4911. 1.4. Emergency Healthcare. The MTF will provide emergency health care to save loss of life or limb and preserve undue suffering for contract personnel for injuries or illness occurring while on duty in the MTF. These services will be billed to the contractor at the current full reimbursement rate through TRICARE. 2. Operator Training. N/A - No operator training is required. 3. Initial Inspection. N/A - No contractor-owned equipment will be brought to the Medical Treatment Facility. 4. Removal of Equipment. N/A - The contractor will not be on site. Equipment shall be mailed to the contractor for repair. Contractor shall be responsible for damage or loss of equipment while in contractor's possession. APPENDIX A Applicable Instructions, Directives and Regulations Publications and forms applicable to this Performance Work Statement (PWS) are listed below, and are mandatory. The contractor shall follow those publications to the extent specified (that is, the specific procedure in a paragraph, section, chapter or volume) to meet requirements in this PWS. Applicable publications are located at http://www.e-publishing.af.mil/pubs. The Government may issue supplements or amendments to listed publications from any organizational level during the life of the contract. The contractor shall keep all issued publications up-to-date. The contractor shall immediately implement those changes in publications that result in a decrease or no change in the contract price. Before implementing any such revision, supplement, or amendment that will result in an increase in contract price, the contractor shall submit to the contracting officer a price proposal for approval. Price proposals shall be submitted within 30 calendar days from the date the contractor receives notice of the revision, supplement, or amendment-giving rise to the increase in cost of performance. The Government and the contractor will negotiate the changes into the contract under provisions of the Changes clause. The Contractor will continue to supply the Government forms needed for daily operations. Upon completion of the contract, the contractor shall return to the Government all issued publications and unused forms. Publications Code: AFI--Air Force Instruction AMC-Air Mobility Command DoDI-DoD Instruction MDGI -60th Medical Group Instruction DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS: Number Title of Directive DoDI 3020.37 Continuation of Essential DOD Contractor Services During Crises DoDI 5400.7-R DoD Freedom of Information Act Para, C.4.2.1, C.4.4C3.2.1.2 - C3.2-1.9 Air Force Sup DoD Freedom of Information Act DoDI 5500.7-R Joint Ethics Regulation (JER) DoDR 6025.18-R Health Information Privacy Regulation AFI 33-129 Transmission of Information via the Internet AMC Sup 1 Transmission of Information via the Internet Internet AFI 33-201 Communications Security (COMSEC) AFI 33-332 Air Force Privacy Act Information AMC Sup 1 Air Force Privacy Act Information Records Disposition Schedule WebRIMSs website at Privacy Act Systems of Records Notice(s) at Appendix B Equipment List Scope Type Scope Model Scope S/N Cystoscope CYF-V2 2720960 Ureterorenoscope URF TYPE V 2940665 Ureterorenoscope URF TYPE V 2141769