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Laws & Regulations Database of The Republic of China (Taiwan)

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1.Signed on September 16 and June 2, 2005; Entered into force on September 16, 2005.
 
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 University

B. 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 have
signed this Implementing Arrangement.

DONE at Washington, D.C., in duplicate, in English language.


FOR THE FOR THE TAIPEI FOR THE AMERICAN INSTITUTE
ECONOMIC IN TAIWAN
AND CULTURAL REPRESENTATIVE
OFFICE IN THE UNITED STATES

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9/16/05 6/2/05
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Date Date
Web site:Laws & Regulations Database of The Republic of China (Taiwan)