30 3 月

IMPLEMENTING ARRANGEMENT NUMBER 2 TO THE GUIDELINES FOR A COOPERATIVE PROGRAM IN PUBLIC HEALTH AND PREVENTIVE MEDICINE BETWEEN THE COORDINATION COUNCIL FOR NORTH AMERICAN AFFAIRS AND THE AMERICAN INSTITUTE IN TAIWAN-1

A. Objectives 1. To establish baseline data on the incidence and prevalence of multidrug-resistant organisms (MDROs) in a cohort of Taiwan hospital ICUs. 2. To evaluate the burden, cost-benefit, and impact of measures undertaken for controlling MDROs in Taiwan hospitals. 3. To assess and implement the cost-effectiveness of active surveillance and isolation (ASI) interventions for controlling MDROs in nosocomial infections of Taiwan hospital. The activities described in this Implementing Arrangement will be carried out under The general terms and conditions established between the American Institute in Taiwan (AIT) and the Coordination Council for North American Affairs, since renamed the Taipei Economic and Cultural Representative Office in the United States (TECRO), in the Guidelines for a Cooperative Program in Public Health and Preventive Medicine, hereinafter referred to as the Guidelines. This Implementing Arrangement is hereby attached to the Guidelines and becomes part of the Guidelines. In carrying out the activities described in this Implementing Arrangement, AIT’s Designated representative shall be the Centers for Disease Control and Prevention/United States Department of Health and Human Services (CDC/USHHS). Within AIT’s designated representative CDC/USHHS, AIT designated topic coordinator for the activities described in this Implementing Arrangement is: L. Clifford McDonald, M.D. Medical Epidemiologist, Epidemiology and Laboratory Branch Division of Healthcare Quality Promotion National Center for Infectious Diseases Centers for Disease Control and Prevention U.S. Department of Health and Human Services In carrying out the activities described in this Implementing Arrangement, TECRO’s Designated representatives shall be the Department of Health of Taiwan (the Office of Science and Technology Development, and the Center for Disease Control of Taiwan), and the National Health Research Institutes of Taiwan (NHRI). Within TECRO’s designated representatives, TECRO’s designated topic coordinator for the activities described in this Implementing Arrangement is: Shan-Chwen Chang, M.D., Ph.D Chief, Division of Infectious Diseases Professor, Department of Internal Medicine National Taiwan UniversityB. Services AIT, through its designated representative CDC/USHHS, will provide the Following services to TECRO’s designated representatives: 1. Technical assistance in preparing study protocol and implementing MDRO control measures to TECRO’s designated representative topic coordinator Prof. S. C. Chang (Principal lnvestigator and Taiwan Program Coordinator). 2. Expertise and assistance in planning and implementing MDRO control measures in study sites including visiting the hospitals studied. 3. Technical assistance in data collection, data analysis, and manuscript preparation. 4. Technical assistance in finalizing guidelines for control and prevention of nosocomial infections of MDRO in other Taiwan hospitals.C. Implementations Plan In Year one, the services described in B. above will be provided in connection with The following plan: 1. Selection of 2 or 3 medium-sized hospitals to initiate the following studies in methicillin-resistant Staphylococcus aureus (MRSA) infection: (a) To perform active surveillance cultures at the time of intensive care unit (ICU) admission to identify patients colonized with MRSA. (b) To weekly collect surveillance cultures so as to continuously monitor the colonization of MRSA among patients at ICUs. (c) To collect and analyze clinical histories of each patient prior to and during their hospitalization particularly in respect to antibiotics prescribed for treatment. (d) To strictly implement contact isolation control once MRSA-carriers and MRSA-infected patients have been identified. (e) To determine and evaluate the cost-effectiveness of Active Surveillance and Isolation (ASI) in hospitals studied. (f) All isolates of MRSA collected from patients will further be examined for their minimum inhibitory concentrations (MICs) of various antibiotics and be subtyped at the molecular level by the laboratory of TECRO’s designated representative NHRI. 2. One or two experts from AIT’s designated representative CDC/USHHS may visit the territory represented by TECRO once or twice a year, of which each trip will take a week, to assist in implementing the study etc. In Year Two, the services described in B. above will be provided in connection with the following plan. In the meantime, the program of MRSA control may be extended to other large-, intermediate- and small-sized Taiwan hospitals based on the good performance from the first year of analyses for cost-benefit and effectiveness of the ASI. In addition, the study will also be independently expanded to cover the study on the incidence and prevalence of pan-drug resistant Acinetobacter baumannii (PDRAB) in Taiwan hospitals in the second year of collaboration. 1. Selection of 2 or 3 medium-sized hospitals to initiate the following studies: (a) To perform active surveillance cultures of patients at the time of ICU admission to identify patients who are colnized with Acinetobacter baumannii. (b) To weekly collect surveillance cultures so as to continuously monitor the colonization of A. baumannii among patients at ICUs. (c) To collect and analyze clinical histories of each patient prior to and during their hospitalization particularly in respect to antibiotics prescribed for treatment. (d) To strictly implement contact isolation control once PDRAB-carriers and PDRAB-infected patients have been identified. (e) To determine and evaluate the cost-effectiveness of ASI in hospitals with respect to PDRAB. (f) Similarly, all isolates of A. baumannii collected from patients will be examined for their minimum inhibitory concentrations (MICs) of various antibiotics and be subtyped at the molecular level by the laboratory of TECRO’s designated representative NHRI. 2. One or two experts from AIT’s designated representative CDC/USHHS may visit the territory represented by TECRO once or twice a year, of which each trip will take a week, to assist in implementing the study etc. In Year three, four and five, the services described in B. above will be provided in Connection with the following plan: Based on results of data collected from the first 2years of study, the study will be extended to the control for other species of nosocomial pathogens such as vancomycin-resistant Enterococus (VRE), vancomycin-resistant Staphylococcus aureus (VRSA), extended spectrum beta-lactamase (ESBL) producing E. coli and Klebsiella pneumoniae, and pan-drug resistant Psudomonas aeruginosa.D. Financial Arrangements 1. All costs for implementation of the program components conducted in the territory represented by TECRO will be born by TECRO through its designated representatives, the Department of Health of Taiwan and the Center for Disease Control of Taiwan. The cost for the activity described in the Implementation Plan for year One of this Implementing Arrangement is mutually agreed not to exceed N. T.$ 5,000,000 (approx. U.S. $150,000). Costs for Years 2-5 will be agreed by TECRO’s designated representative the Department of Health of Taiwan, depending on the evaluation of cost-effective analyses, reports, and data from the first year. Grants will be funded to the TECRO’s designated representative topic coordinator by TECRO’s designated representative the Center for Disease Control of Taiwan. 2. The sending party shall ensure that its designated representative bears the international fares of the designated representative’s staff. The receiving party shall ensure that its designated representative will cover the local costs of the visit. 3. The host party’s designated representative will not cover the costs of accompanying dependants, insurance or medical costs during the visit. 4. Should AIT’s designated representative CDC/USHHS hold any conference or symposium on a related subject and invite scholar(s) from the territory represented by TECRO to attend, costs for the trip would be similarly apportioned as described in Section D.2. 5. Based upon this apportionment of funding and travel costs, there is no anticipated need for money to be exchanged between AIT and TECRO or their designated representatives. However if an unforeseen need for such exchange should arise, all monetary exchanges shall be conducted via AIT and TECRO.E. Intellectual Property Considerations No intellectual property rights (IPR) are expected to arise in conjunction with activities described in this Implementation Arrangement. TECRO and its designated representatives, the Department of Health of Taiwan, Office of Science and Technology Development, Center for Disease Control of Taiwan, National Health Research Institutes, and participating hospitals in Taiwan are requesting the expertise and knowledge of AIT’s designated representative CDC/USHHS to assess the risk of nosocomial transmission in S. aureus and other species of pathogens as previously described. The objective of the cooperative activities is to strengthen nosocomial infection control in Taiwan hospitals. Reference reagents may be provided. All activities are nonpatentable. The TECRO-designated representative topic coordinator shall be the lead on all manuscripts, whilst other collaborators from TECRO’s designated representatives NHRI and CDC/USHHS will be designated as the co-authors. The annual Implementation Plan shall not be distributed to other parties until it has been approved in final form by AIT’s designated representative, the CDC/USHHS, and TECRO’s designated representative, Center for Disease Control of Taiwan.F. Effective Data This Implementation Arrangement is effective on the data of the last signature hereafter.G. Amendment and Termination This Implementation Arrangement may be amended or terminated in accordance with The terms of the Guidelines.IN WITNESS WHEREOF, the undersigned, being duly authorized havesigned this Implementing Arrangement.DONE at Washington, D.C., in duplicate, in English language.FOR THE FOR THE TAIPEI FOR THE AMERICAN INSTITUTEECONOMIC IN TAIWANAND CULTURAL REPRESENTATIVEOFFICE IN THE UNITED STATES────────────── ──────────────9/16/05 6/2/05────────────── ──────────────Date Date