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MINISTRY
OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.
127/QD-BYT
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Hanoi,
January 15, 2019
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DECISION
ISSUANCE
OF “GUIDELINES ON NATIONAL ANTIMICROBIAL RESISTANCE SURVEILLANCE”
MINISTER OF HEALTH
Pursuant to the Law on
Medical Examination and Treatment in 2009;
Pursuant to Decree No.
75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers,
and organizational structure of Ministry of Health;
At the request of Director
General of Vietnam Administration of Medical Services,
HEREBY DECIDES:
Article
1. “Guidelines on
national surveillance of antimicrobial resistance” are attached to this
Decision
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Article
3. This Decision comes
into effect from the day of signing.
Article
4. Chief of the Ministry
Office, Chief Ministry Inspectorate, Director General, Directors of General
Departments, Departments affiliated to Ministry of Health, Directors of
Departments of Health of provinces and central-affiliated cities, Chairpersons
of Hospitals and Institutes affiliated to Ministry of Health, heads of medical
sector shall implement this Decision./.
PP. MINISTER
DEPUTY MINISTER
Nguyen Viet Tien
GUIDELINES
ON NATIONAL SURVEILLANCE OF ANTIMICROBIAL RESISTANCE
(Attached to Decision No. 127/QD-BYT dated January 15, 2019 of Minister of
Heath)
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INTRODUCTION
Abstract
Policy framework
Surveillance objectives
Course
Antimicrobial resistance
surveillance unit
CHAPTER 1. SURVEILLANCE METHODS
1. Group
2. Microbiology
methods and Antimicrobial Susceptibility Testing (AST)
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4. Data
to be reported to VNASS
5. Elimination
of duplicate data
6. Data
submission to AMR Unit
CHAPTER 2: PRIORITIZED
PATHOGENS, SPECIMENS AND AST FOR DATA ANALYSIS
Pathogens and clinical
specimens
CHAPTER 3: SURVEILLANCE AND
REPORT STANDARDS
1. Microbiology
laboratories
2. AMR Unit
1. Data
adequacy:
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ANNEX A1
LIST OF MANDATORY
ANTIMICROBIALS TO BE TESTED
ON PRIORITIZED PATHOGENS
ANNEX B:
REPORT ON GROUPS AND COLLECTION
OF MONTHLY CULTURE DATA
ANNEX C:
INSTRUCTION ON HOW TO UPLOAD
A WHONET FILE
ON THE AMR WEBSITE: kks.kcb.vn
1. Introduction
2. Log
in
3. Interface
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ACRONYMS
AMR
Antimicrobial
resistance
AST
Antimicrobial
susceptibility testing
ATCC
American Type
Culture Collection
CLSI
Clinical &
Laboratory Standards Institute
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External quality
assurance
GLASS
Global
Antimicrobial Resistance Surveillance System
IPC
Infection
Prevention and Control
MOH
Ministry of Health
NCC
National
coordinating center
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Quality control
VAMS
Viet Nam
Administration for Medical Services
VNASS
Viet Nam
Antimicrobial Resistance Surveillance System
WHO
World Health
Organization
INTRODUCTION
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Antimicrobial resistance is
a threat to global health. In modern medicine, antimicrobial is one of the
important methods of medical treatment which effectively treats
life-threatening infections and prevents infectious complications caused by
regular medical intervention or surgery. However, the appearance of
antimicrobial resistant microbes has posed a threat to patients’ lives since
such microbes grow resistant to many types of antimicrobial and in some cases,
to all of the existing antimicrobials.
In a global travel era, many
forms of antimicrobial resistance can easily spread from one region to another
which means the appearance of antimicrobial resistance in any region is a worldwide
threat. Global health community already admits the urgency of the
antimicrobial resistance crisis. Since 2015, Global Health Council adopted the Global
Action Plan on Antimicrobial Resistance.
With the participation in
the global antimicrobial resistance network, Vietnam pursues a deeper
understanding and restriction on the antimicrobial resistance threat. In
Vietnam, cases of antimicrobial resistance infection each year are in large
numbers (without specific statistical data), many of which are infections contracted
at medical facilities. This leads to unacceptable risks to patients' safety and
imposes a considerable burden on health system of Vietnam.
However, the levels of
infiltration and spread of antimicrobial resistance in Vietnam are not fully
comprehended yet. Vietnam guarantees to implement a standardized antimicrobial
resistance system to have a clearer view on the antimicrobial resistance threat
and to make every effort to minimize it.
Policy framework
In the National Action Plan
in 2013 to combat antimicrobial resistance for the period 2013 – 2020, Vietnam
guaranteed to increase national surveillance with respect to antimicrobial
resistant microbes, and to raise the awareness within the community and health
sector of the risk of uncontrolled antimicrobial resistance in Vietnam. The
action plans has furnished with a solution of multiple approaches including
ensuring adequate and sufficient medication, encouraging the safe and
reasonable medical use of antimicrobials, enhancing the measures to prevent and
control infections as well as use antimicrobials safely and reasonably on
livestock, poultry and fishery. In 2013, the Vietnam
Resistance (VINARES) Project, which is collaboration between the Oxford
University Clinical Research Unit (OUCRU) and 16 nationwide testing labs, was
implemented in order to cope with antimicrobial resistance related issues in
health sector and to establish the initial antimicrobial resistance
surveillance network.
On October 17, 2016,
Ministry of Health promulgated Decision No. 6211/QD-BYT on establishment and
functions, tasks of surveillance network of antimicrobial resistant microbes in
medical examination and treatment facilities. This
Decision is a foundation in the establishment of surveillance network of
antimicrobial resistant microbes in health facilities, including the 16 testing
labs in the initial implementation of the antimicrobial resistance surveillance
network (Table 1). Decision No. 6211/QD-BYT specifies roles and
responsibilities of the surveillance system.
Table
1. Core surveillance facilities in initial implementation phase
Name of hospitals
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Region
1. Bach
Mai Hospital
Ha Noi
Northern region
2. National
Hospital for Tropical Diseases
Ha Noi
Northern region
3. National
Hospital of Pediatrics
Ha Noi
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4. Vietnam-Germany
Friendship Hospital
Ha Noi
Northern region
5. Saint
Paul General Hospital
Ha Noi
Northern region
6. Vietnam-Czech
Friendship Hospital
Hai Phong
Northern region
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Quang Ninh
Northern region
8. Hue
Central Hospital
Hue
Middle region
9. Da
Nang General Hospital
Da Nang
Middle region
10. Binh
Dinh Provincial General Hospital
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Middle region
11. Dak
Lak Provincial General Hospital
Dak Lak
Middle region
12. Khanh
Hoa General Hospital
Khanh Hoa
Middle region
13. Cho
Ray Hospital
Ho Chi Minh
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14. Ho
Chi Minh City Hospital for Tropical Diseases
Ho Chi Minh
Southern region
15. Children’s
Hospital No. 1
Ho Chi Minh
Southern region
16. Can
Tho Central General Hospital
Can Tho
Southern region
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Objectives of the Viet Nam
Antimicrobial Resistance Surveillance System (VNASS) include collection,
analysis and share of standardized data to recommend actions in local scale,
national scale and global scale to minimize the antimicrobial resistance. Specific
objectives of the surveillance system include:
. Determine characteristics
of pathogens at hospitals.
. Monitor any changes in the
models of antimicrobial resistance over specific period and identify new
antimicrobial resistant pathogens.
. Increase capacity of microbiology
laboratories in conducting identification and antimicrobial susceptibility
tests to detect the pathogens.
. Provide information on
national policy on infection control.
. Implement infection
control activities following objectives at hospitals based on local
antimicrobial resistance data.
. Analyze and share national
and international antimicrobial resistance data by reporting to GLASS - Global
Antimicrobial Resistance Surveillance System of World Health Organization
(WHO).
To implement the national
antimicrobial resistance surveillance system satisfactory to the objectives set
forth, Ministry of Health prepares the Guidelines on antimicrobial resistance
surveillance. This document provides solutions on premature adoption of
standardized antimicrobial resistance surveillance in Vietnam, including surveillance
methods; roles and responsibilities in local, regional and national scale; and
requirements of data collection, management and report. This documents aims at
16 core testing laboratories, who are affiliated to the initial Antimicrobial Resistance
Surveillance System.
Course
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16 core facilities adopted the
software for management of microbiology laboratory data – WHONET via VINARES
Project. This is a free multilingual program developed by the
Antimicrobial Resistance Surveillance and Quality Assessment Collaborating
Centers of World Health Organization and used as a surveillance platform for
VNASS. Laboratories will receive preliminary responses and analysis
regarding surveillance data and technical support to connect WHONET to routine
data flows of laboratories, standardize reports and improve data quality in
first few years of implementation. When
standardized data are jointly reported to VNASS, surveillance results shall be
shared on a national scale and to GLASS on a yearly basis. Relevant
parties shall arrange periodic appointments to assess process and exchange
ideas regarding future orientation of the Surveillance System.
Antimicrobial Resistance Surveillance
Unit
Antimicrobial Resistance
Surveillance Unit (hereinafter referred to as “AMR Unit”) at Vietnam
Administration of Medical Services shall act as a national coordinating center
affiliated to VNASS. The AMR Unit includes experts in infectious diseases,
epidemiology, microbiology and information technology and is responsible for:
- Develop
surveillance methods and requirements of antimicrobial resistance surveillance
reports.
- Verify
compliance with internal quality control and external quality assessment
programs and inspect results of the external quality assessment of laboratories
under the Surveillance System.
- Accept
and manage surveillance data from all of the testing laboratories in the
network.
- Respond
to requests of the testing laboratories.
- The
AMR Unit shall satisfy requirements relating training and technical support of
the laboratories in the Surveillance System. The
AMR Unit shall cooperate with domestic and international microbiology experts
or national AMR technical teams to develop policies, decisions and guidelines
on antimicrobial resistance surveillance.
CHAPTER 1. SURVEILLANCE METHODS
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Patient groups of 16 core surveillance
facilities include patients of all age groups in northern, middle and southern
regions nationwide. The laboratories in the Surveillance System shall be required
to fully provide data about patients at the facilities on a yearly basis. Such
information shall be reported via the AMR website once per year (more details
under Annex B: Report on group and monthly report on collection of culture data).
2.
Microbiology methods and Antimicrobial Susceptibility Testing (AST)
Isolation, identification
and AST must follow international standards set forth in M100 document of
Clinical and Laboratory Standards Institute (CLSI) (the document is updated on
a yearly basis).
Antimicrobial susceptibility
tests on pathogens must follow any of the methods below:
- Kirby
Bauer disk diffusion method: reported result is the diameter
of zone of inhibition.
- Automated
antimicrobial susceptibility method (e.g. Vitek, Phoenix, Microsan): reported
result is the Minimum Inhibitory Concentration (MIC) value.
- Gradient
diffusion method: reported result is the MIC value.
The AST results of pathogens
prioritized for surveillance must be reported as the diameter of the zone of
inhibition or the MIC values. In case a testing laboratory
is unable to convert the result in the form of the diameter of the zone of
inhibition and the MIC value to a WHONET file, they can report as Sensitive
(S), Intermediate (I) or Resistant (R). Meanwhile, the AMR Unit shall continue
to collaborate with the testing laboratory to rectify and report the data in
the form of the diameter of zone of inhibition and the MIC value.
3.
Data input into WHONET
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a) Prioritized option: Load
all positive and negative culture data into WHONET and sent the file to
AMR website of Vietnam Administration of Medical Services (kks.kcb.vn).
OR
b) Load all positive culture
data into WHONET and sent monthly file to the AMR website of Vietnam
Administration of Medical Services (kks.kcb.vn). In
the meantime, report on total specimens positively and negatively cultured of
the testing laboratories to the website on a monthly basis as set forth under Annex
B – Report on group and monthly report on collection of culture data.
The testing laboratories may
load data into WHONET at any time in a month; however, loading on a daily basis
is recommended to ensure timely and complete data submission.
4.
Data to be reported to VNASS
The following testing lab
codes according to WHONET shall be applicable to 16 testing laboratories in the
AMR Surveillance System:
Table
2. Testing lab codes according to WHONET
Unit/Testing
laboratory
Testing
lab code
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Testing
lab code
Bach Mai Hospital
BMA
Da Nang General Hospital
DNG
National Hospital for
Tropical Diseases
CLI
Binh Dinh Provincial
General Hospital
BID
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VCH
Dak Lak Provincial General
Hospital
016
Vietnam – Germany Hospital
VD
Khanh Hoa General Hospital
KH
Saint Paul General
Hospital
123
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CRH
Vietnam – Czech Friendship
Hospital
H06
Ho Chi Minh City Hospital
for Tropical Diseases
HTD
Vietnam – Sweden Hospital,
Uong Bi
UBI
Children’s Hospital No. 1
CH1
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HUE
Can Tho Central General
Hospital
WTH
The testing laboratories
shall send all results of bacterial culture of specimens taken
from the clinical departments. Data fields in specification
of a standardized testing laboratory according to WHONET are listed in Table
3. Information in each data fields must be completely inputted and reported
with respect to each case of isolation and information of the whole file must
also be completely inputted and reported. Additional
data fields may be added to the specification of a WHONET testing laboratory
depending on the demand of each testing laboratory.
Table
3. Mandatory data field applicable to specification of a WHONET testing
laboratory
WHONET data field
Definition
Format
Institution
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ID code consists of 3
digits representing the hospital where the specimen is collected
Consult Table 2
Laboratory
ID code consists of 3
digits representing the testing laboratory where the specimen is tested
Consult Table 2
Patient_ID
Number of medical record
or other unique identification number attached to the patient during hospital
registration or admission
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Sex
Patient’s gender
Male, Female or Other
Date_Birth
Patient’s date of birth
(required for patients ≤ 2 years old)
DD/MM/YYYY
Age
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Patient’s age, round down
to the nearest integer
Age (≥ 1 year old)
Month (< 1 year old, ≥
1 month old)
Day (< 1 month)
Date_Admission
Date on which the patient
is admitted to the hospital
DD/MM/YYYY
Ward_Type
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Type of rooms where the
patient stays at the time of specimen collection
Intensive Care Unit (ICU),
Inpatients other than ICU, Outpatients.
Department
Name of department where
the patient stays at the time of specimen collection
Depends on respective
department (e.g. paediatrics, cardiology, etc.)
Spec_Num
Unique code attached to
each specimen when collected by the testing laboratory
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Spec_Date
Date on which the patient
may take the specimen
DD/MM/YYYY
Spec_Type
Type of specimen collected
from the patient
E.g. blood, urine,
respiratory fluids, cerebrospinal fluids, other sterile bodily fluids, stool,
wound, etc.
Organism
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Specify the genus and
species (if possible) of the isolated pathogen.
Standard format in WHONET
ASTa
Results of antimicrobial
resistance conducted by disk diffusion, automated AST or gradient diffusion.
Disk diffusion: Diameter
of zone of inhibition (mm)
Automated AST: MIC value
(µg/ml)
Gradient diffusion: MIC
value (µg/ml)
aNote:
in case the testing laboratory is unable to provide the results of AST in the
form of diameter of the zone of inhibition or MIC value, may report the AST
results as Sensitive (S), Intermediate (I) or Resistant (R) for each
antimicrobial.
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5.
Elimination of duplicate data
After the AMR Unit has
received the WHONET files, duplicate data of the same patient will be
eliminated (deduplicated). The data deduplication shall
be implemented in every surveillance phase in order to collect the first result
per patient for analysis based on the type of specimens and pathogens that were
surveyed. When negative culture results are loaded into WHONET, any duplicate
of the negative culture sample of the same specimen of one patient will also be
deduplicated.
In order to ensure that the
deduplication functions properly, the facilities must guarantee that all
culture results are attached in the WHONET files and sent to Vietnam
Administration of Medical Services and that each result shall be give one
unique patient ID expressed by either number or numeral (the name of the data
field according to WHONET is: “Patient_ID"). This
unique patient ID is usually the number on the medical record assigned by a
hospital during the process of registering a patient into a medical facility. If a
hospital does not have a standardized system to assign the number of the
medical record (or the unique patient ID), inform the AMR Unit and when sending
the file, specify a patient’s full name until a solution to this issues is
achieved.
6.
Data submission to AMR Unit
a) Report frequency
The testing laboratories
must collect and report the data with adequate quality, before the time limit
and in a manner satisfactory to the report requirements. Each
testing laboratory shall integrate the AMR data (including the disk diffusion,
automated and E-test methods) of 1 month into a single WHONET file and upload
it on the secure website of Vietnam Administration of Medical Services: kks.kcb.vn. Deadline
for report submission: before the 10th of the following month (e.g. data from
January 1, 2019 to January 31, 2019 shall be uploaded on the website kks.kcb.vn
before February 10, 2019).
b) File format
The data must be integrated
and submitted in a single WHONET file, which includes the result of the AST
conducted by following the disk diffusion and MIC methods. Instruction
on how to create a WHONET file in Annex C - Instruction on how to upload a
WHONET file on the AMR website kks.kcb.vn. Each
file shall be named following a standardized format including the testing lab
code expressed by 3 letters, month (MM) and year (YYYY). E.g.
data of January 2018 of Bach Mai Hospital shall be named BMH_012018. The AMR
Unit collaborating with international stakeholders and domestic microbiology
experts shall provide technical assistance for the testing laboratory to adjust
the WHONET specification in order to achieve the minimum report standards,
integrate WHONET into the data flows of the testing laboratory and consolidate
monthly file to send to the AMR Unit.
c) Submission to the secure
website: Instruction on how to upload a file on the AMR secure website
is specified in Annex C.
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Pathogens and clinical
specimens
The testing laboratories
shall send all of the bacterial culture results of routine specimens that were
tested at clinical request. The data shall be
prioritized for analysis and quality control as described in Table 4. In
order to ensure standardization and quality of the microbiology data reported
to Vietnam Administration of Medical Services, the minimum requirements of AST
testing and report applicable to prioritized bacteria are described in Annex
A1, A2 and are based on guidelines in the document CLSI M100:
Table
4. Pathogens and specimens prioritized for surveillance
Specimens
Bacteria prioritized for
surveillance
Blood
E. coli
K. pneumoniae
A. baumannii
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S. pneumoniae
Salmonella spp.
Urine
E. coli
K. pneumoniae
Stool
Salmonella spp.
Shigella spp
Urethra and vaginal
discharge
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Specimens from other
sterile parts of the body
Cerebrospinal fluid
Fluid in joints
Fluid in hip joint
Pleural effusion
Pericardial fluid
Synovial fluid
Peritoneal cavity fluid
Pus from abscess
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Acinetobacter spp.
Escherichia coli
Enterococcus spp.
Klebsiella spp.
Pseudomonas spp.
Staphylococcus aureus
Streptococcus pneumoniae
CHAPTER 3: SURVEILLANCE AND REPORT STANDARDS
1.
Microbiology laboratories
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. Capable of specimen
collection, bacteria culture and identification, and AST according to standards
of CLSI.
. Ready to participate in
testing laboratory assessment to improve the capacity of antimicrobial
resistance testing and surveillance.
b) Procurement of testing
laboratory facilities and equipment maintenance
. Provide appropriate
storage for all necessary reagents, biologicals and facilities to ensure the
availability of the culture, identification tests and AST at all time.
. Comply and maintain
documents on equipment maintenance and repair or documents on equipment replacement
accordingly when necessary.
. Develop backup plans to
prevent the testing services from being interrupted due to facility shortage or
damage. If a testing laboratory temporarily or permanently fails to
maintain the appropriate facilities and equipment to rectify the interrupted
testing services, inform the AMR Unit as soon as possible.
c) Internal quality control
. Conduct quality control
activities for each type of environment, reagents and antimicrobials with
appropriate frequency according to the international standards publicized by
CLSI or similar and use standard reference types such as ATCC (the AMR Unit
shall provide at least 18 types satisfactory to ATCC together with type
documents for 16 testing laboratories conducting AST quality control activities).
. Record results of implemented
quality control and remedial measures; fully archive documents.
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. Participate in the monthly
EQA program to monitor the accuracy and reliability of identification testings
and AST results [with respect to the initial implementation, participate in the
United Kingdom National External Quality Assessment Service (NEQAS)].
. Participate in inspection
and assessment to results of the external quality assessment and adjust the unsatisfactory
results of the external quality assessment with the assistance of OUCRU,
Vietnam’s microbiology experts and international stakeholders if necessary.
dd) Archive and submission
of some special isolated types
. The testing laboratories
shall archive and send some isolated types deemed as special regarding
epidemiology or biology to reference labs to conduct confirmation tests and
identify molecular biological properties of drug resistance.
e) Data management
. Ensure enough employees
and adequate facilities to implement antimicrobial resistance surveillance.
. Ensure that employees are
adequately trained regarding collection, analysis and report of antimicrobial
resistance data in epidemiological, clinical and testing perspectives.
. Provide sufficient time to
enable the employees to collect, check and report the surveillance data
promptly, completely and in a manner satisfactory to the AMR Unit.
. Develop measures to share
AMR data with Infection Prevention and Control Departments and clinical
departments at least on a quarterly basis.
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. Produce separate reports
for each hospital on the pathogens and models of antimicrobial sensitivity
("Cumulative antiogram of hospital”) on a yearly basis to share with
clinical departments and doctors to guide the prescription practices based on
the local antimicrobial sensitivity models.
2.
AMR Unit
In order to successfully
implement and coordinate the Surveillance System, the AMR Unit shall consist of
key personnel of VAMS having responsibilities that are necessary to aid VNASS
in performing following tasks:
a) Strategic leadership
. Supervise and coordinate
operation of the National Surveillance System of Antimicrobial Resistance.
. Develop surveillance
methods and report requirements applicable to testing laboratories
participating in the Surveillance System.
. Identify necessary strategies
to successfully participate in GLASS
. Represent VNASS in
meetings, seminars, meetings of relevant parties and other relevant national
and international forums.
. Cooperate with other units
in Ministry of Health in antimicrobial resistance surveillance following “One
Health” approach.
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. Encourage relevant parties
in testings at hospitals to participate in the antimicrobial resistance
surveillance at hospitals
. Act as the link between
heads of Ministry of Health and units carrying out surveillance.
b) Quality assurance
. Develop and publicize
standard AMR surveillance guidelines, procedures and tools based on consultation
with international stakeholders and technical teams when necessary.
. Verify compliance with
internal quality assurance and external quality assessment programs of testing
laboratories under the Surveillance System.
. Verify availability of
qualified facilities, chemicals and biologicals in the testing laboratories
under the Surveillance System.
. Satisfy training and
technical assistance demands of the testing laboratories under the Surveillance
System.
c) Data management and
report
. Ensure accessibility to
WHONET software of all testing laboratories to facilitate reports on
surveillance data and WHONET update at least on a yearly basis.
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. Supervise the monthly
submission of WHONET files to ensure the files are submitted within the time
limit and completely.
. Conduct periodic
examination of data quality of WHONET files: compliance with guidelines of
CLSI, compliance with AMR procedures, legitimacy in microbiology and
conformance in interpretation sessions of AST results based on the size of the
zone of inhibition and MIC values.
. Notify the testing
laboratories promptly of data quality flaws and debate about rectification.
. Provide remote or onsite
technical assistance to enable the testing laboratories to integrate WHONET
into data management procedures and optimization of data collection and report.
. Report annual consolidated
AMR surveillance data to the testing laboratories affiliated to the Surveillance
System and relevant parties while ensure information security relating data and
origin thereof, eliminate all hospital identification from the consolidated
data.
. Consolidate and send the
annual consolidated AMR surveillance data to GLASS.
. Provide interpreted data
to facilitate the use thereof in policy development and guidelines.
CHAPTER IV: SURVEILLANCE AND ASSESSMENT
Starting from 2019, the AMR
Unit shall regularly supervise VNASS regarding data submission and data quality
with assistance of domestic microbiology experts and international
stakeholders. The AMR Unit shall calculate the data quality and data
adequacy indices on a monthly basis and display response to each testing
laboratory on the AMR website. The AMR Unit may also
respond, collect information and provide technical assistance for the testing
laboratories and vice versa via telephones or face-to-face meetings at
facilities when necessary.
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Data indices shall include
but not limited to:
1.
Data quality and adequacy:
- Percentage
of data submission within the time limit, per testing laboratory.
- Percentage
of mandatory variables required in a WHONET file as specified in Table 3.
- Adequacy
of data variables in each submitted WHONET file.
- Percentage
of facilities complying with the guidelines of the CLSI on prioritized
pathogens based on criteria listed in Annexes A1, A2. This supervision
exercised by the AMR Unit shall include:
. Antibiotic panel suitable
for specimens and origins thereof.
. Attached appropriate
legends.
. Conflicted or unreasonable
AST results based on data examination.
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- Percentage
of testing laboratories performing internal control at least on a weekly basis.
- Percentage
of testing laboratories recording rectifying measures provided unsatisfactory
quality control.
- Percentage
of testing laboratories participating in monthly EQA.
- Percentage
of testing laboratories whose month EQA results are qualified.
- Percentage
of testing laboratories recording rectifying measures provided unsatisfactory
EQA.
In 2019, Ministry of Health
shall assess the VNASS. Assessment teams shall be established by Ministry of Health
consisting of representatives of the AMR Unit, domestic microbiology experts
and international stakeholders. The assessment shall rely on
the objectives and organizational structure of the Surveillance System
described in this document. Members in the assessment
teams shall work together to design the assessment in order to describe and
improve the capacity of the program implementation. Document
used in the assessment of the Surveillance System is the frame for program
assessment developed by CDC and adjusted to suit Vietnam (Updated guidelines
for evaluating public health surveillance system, CDC 1999). The assessment
results shall be reported and publicized by the AMR Unit in joint format. This
result shall be used to adjust the “Guidelines for National Surveillance of
Antimicrobial Resistance” before expanding the Surveillance System.
ANNEX
A1
LIST OF MANDATORY ANTIMICROBIALS TO BE TESTED
ON PRIORITIZED PATHOGENS
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Furthermore, hospitals must
supervise and report another 5 types of bacteria popular at their facilities
provided 10 popular bacteria thereof do not include 8 bacteria listed in the
table below (e.g. Steno/blood; Suit/cerebrospinal fluid or blood, whitmore,
etc.)
Bacteria
Antimicrobials
selected for AST
Escherichia coli
Co-trimoxazole
Ciprofloxacin or
levofloxacin
Ceftriaxone or cefotaxime
and ceftazidime
Cefepime
Imipenem, meropenem,
ertapenem or dorpenem
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Ampicillin
Klebsiella pneumoniae
Co-trimoxazole
Ciprofloxacin or
levofloxacin
Ceftriaxone or cefotaxime
and ceftazidime
Cefepime
Imipenem, meropenem,
ertapenem or dorpenem
Colistin
Acinetobacter baumannii
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Gentamicin and/or amikacin
Imipenem, meropenem, or
dorpenem
Colistin
Staphylococcus aureus
Cefoxitin
Streptococcus pneumoniae
Oxacillin, Penicillin G
Co-trimoxazole
Ceftriaxone or cefotaxime
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Ciprofloxacin or
levofloxacin
Ceftriaxone or cefotaxime
and ceftazidime
Imipenem, meropenem,
ertapenem or dorpenem
Shigella spp.
Ciprofloxacin and
levofloxacin
Ceftriaxone or cefotaxime
and ceftazidime
Azithromycin
Neisseria gonorrhea
Cefixime, Ceftriaxone
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Ciprofloxacin
ANNEX
A2
LIST OF SUGGESTED ANTIMICROBIALS TO BE TESTED
ON PRIORITIZED PATHOGENS
(compliance
of testing laboratories are recommended)
The list of antimicrobials
tested on pathogens in table below is testing and report requirements recommended
for compliance of testing laboratories upon joining the antimicrobial
resistance system.
The list is developed based
on the M100 document, Table 1A and 1B of CLSI. Testing
laboratories may order/test other antimicrobials depending on hospital
policies. In case a testing laboratory encounters difficulty following
this table of antimicrobials or has the desire to debate about replacement of
any microbial listed in this table, they must contact the AMR Unit.
Testing laboratories must
fully comply with all applicable guidelines of CLSI for microbial testings and
reports specified in the M100 document and in the legends of Table 1A and
general remarks at end of Tables 2A, 2B-1, 2B-2, 2C, 2D and 2G in particular. Some
descriptions and remarks have been added to tables below
Testing laboratories using
automated AST must also comply with restrictions mentioned in guidelines of
each standard test kit currently in use. With
respect to testing laboratories using the Vitek system, standard test kits of
GN74, GP67 and GP74 are recommended (applicable to Strep pneumoniae). With
respect to testing laboratories using the Phoenix system, standard test kits of
NMIC-121, -123, or -124; PMIC-100, -101 or -102; and SMIC-101 are recommended.
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Antimicrobial group
Supervised microbials
GRAM-NEGATIVE
Escherichia coli,
Klebsiella pneumoniae
Cooperative with
beta-lactamase inhibitor
Amoxicillin-clavulanate or
Ampicillin-sulbactam or Piperacillin-tazobactam (choose at least one).
First-generation
Cephalosporin
Cefazolin1
Third-generation
Cephalosporin
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Fourth-generation
Cephalosporin
Cefepime
Cephamycin
Cefoxitin
Carbapenem
Imipenem or Meropenem
(choose at least one)
Aminoglycoside
Gentamicin and Tobramycin
and Amikacin
Fluoroquinolone
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Nitrofuran
Nitrofurantoin (only for
urine isolates)
Folate antagonists
Trimethoprim-Sulfamethoxazole
(also known as Co-trimoxazole)
Lipopeptide
Colistin2 or
Polymyxin B2 (choose at least one, only BMD method)1
Salmonella spp1
and Shigella spp3
Penicillin
Ampicillin
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Ceftriaxone or Cefotaxime
(only for testing on isolates of blood and CFS, not on isolates of stool)
(choose at least one).
Fluoroquinolone
Ciprofloxacin or
Levofloxacin (choose at least one)
Folate antagonists
TMP/SMX (also known as
Co-trimoxazole)
Phenicol
Chloramphenicol6
Pseudomonas aeruginosa
Cooperative with
beta-lactamase inhibitor
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Third-generation
Cephalosporin
Ceftazidime
Fourth-generation
Cephalosporin
Cefepime
Carbapenem
Imipenem or Meropenem
(choose at least one)
Monobactam
Aztreonam
Aminoglycoside
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Fluoroquinolone
Ciprofloxacin or
Levofloxacin (choose at least one)1
Lipopeptide
Colistin2 or
Polymyxin B2 (choose at least one, only applicable to BMD method)
Acinetobacter
baumannii-calcoaceticus complex
Cooperative with
beta-lactamase inhibitor
Ampicillin-sulbactam or
Piperacillin-tazobactam (choose at least one).
Third-generation
Cephalosporin
Ceftazidime and Cefotaxime
or Ceftriaxone (choose at least one).
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Cefepime
Carbapenem
Imipenem or Meropenem
Aminoglycosides
Gentamicin and Tobramycin
and Amikacin
Fluoroquinolones
Ciprofloxacin1 or
Levofloxacin1 (choose at least one).
Tetracyclines
Tetracycline1 (report
is applicable to urine isolates only).
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Folate antagonists
TMP/SMX (also known as
Co-trimoxazole)
Lipopeptide
Colistin2,
Polymyxin B2 (choose at least one, only BMD method)
GRAM-POSITIVE
Staphylococcus aureus
Cephamycin
Cefoxitin2 (may
be replaced by Oxacillin only if adopt MIC method)
Macrolide
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Lincosamide
Clindamycin1,6
Folate antagonists
TMP/SMX (also known as
Co-trimoxazole)
Glycopeptide
Vancomycin (only for MIC
method)4.
Oxazolidinone
Linezolid
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Tetracycline1,4
or Doxycycline1,4 or Minocycline1,4,6 (choose at least
one).
Ansamycin
Rifampin5 (for
cooperative treatment only)
Aminoglycoside
Gentamicin (for
cooperative treatment only)6
Fluoroquinolone
Ciprofloxacin1
or Levofloxacin1 or Moxifloxacin1 (choose at least
one).
Nitrofuran
Nitrofurantoin (only for
urine isolates)
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Penicillin
Penicillin8 and
Ampicillin9
Glycopeptide
Vancomycin
Oxazolidinone
Linezolid
Nitrofuran
Nitrofurantoin (only for
urine isolates)
Streptococcus pneumoniae*
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Penicillin
Screening10 by
Oxacillin disk diffusion (1ug) and/or Penicillin (only for MIC method)11
Third-generation
Cephalosporin
Cefotaxime13
(only for MIC method) or Ceftriaxone13 (only for MIC method)
(choose at least one).
Carbapenems
Meropenem13
(only for MIC method).
Fluoroquinolones
Levofloxacin1
(not for isolates from CSF).
Tetracycline
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Folate antagonists
TMP/SMX (also known as
Co-trimoxazole)
Glycopeptide
Vancomycin
________________________
1 WARNING:
The following antimicrobials are not routinely reported for bacteria isolated
from cerebrospinal fluid (CSF): first and second-generation cephalosporin and
cephamycins, Clindamycin, Macrolides (e.g. Erythromycin, Azithromycin),
Tetracycline and Fluoroquinolones which are orally administered microbials. These
are not drugs of choice and may not be effective in treating CSF infections.
2 Only perform Colistin/Polymyxin B testings with respect to
carbapenem resistant isolates. Submit
a culture specimen for each isolate of this type to a reference laboratory for
identification or confirmation tests regarding molecule properties testings.
The only approved testing method is MIC by broth microdilution. Should not use
disk diffusion and gradient diffusion.
3 WARNING:
For Salmonella spp. and Shigella spp., 1st- and 2nd-generation cephalosporins
and cephamycins may appear active in vitro but are not effective
clinically and should not be reported as susceptible.
4 Organisms that are
susceptible to tetracycline are also considered susceptible to doxycycline and
minocycline and may be reported as susceptible without further testing,
regardless of specimens. However, organisms concluded as intermediate or resistant to
tetracycline may appear susceptible to doxycycline and/or minocycline and must
be tested against each antimicrobial to determine.
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6
Some agents are not routinely reproted for organisms isolated from unirary
tract: Macrolides, Lincosamides, Minocycline, Chloramphenicol.
7 Only
perform MIC using vancomycin otherwise refrain from conducting AST. May
not conduct Vancomycin AST for all S.aureus isolates if this is not a
routine task of the testing laboratories. Send
any S.aureus isolates whose vancomycin AST results using MIC appear to
be > 8ug/ml to a standardized testing laboratories.
8
Rifampin should not be used alone for antimicrobial therapy.
9 For
staphylococci that test susceptible, aminoglycosid is used only in combination
with other active agents that test susceptible.
10 WARNING:
For Enterococcus spp., cephalosporins, aminoglycosides (except for high-level
resistance testing), clindamycin and co-trimoxazol may appear active in vitro,
but are not effective clinically and should not be reported as susceptible.
11
Enterococci susceptible to penicillin are predictably susceptible to
ampicillin, amoxicillin, ampicillin-sulbactam, amoxicillin-clavulanate,
piperacillin and piperacillin-tazobactam for non–β-lactamase-producing
enterococci. However, enterococci susceptible to ampicillin cannot be
assumed to be susceptible to penicillin.
12
With respect to Enterococcus spp. results of ampicillin testing as
susceptible can be used to predict results for amoxicillin.
13 Isolates
of Pneumococcus having oxacillin zone to be ≥ 20mm are susceptible to
penicillin. For isolates with oxacillin zones ≤ 19 mm, do not report
penicillin as resistant without performing a penicillin MIC test. Penicillin
and cefotaxime, ceftriaxone, or meropenem MICs should be determined for
isolates with oxacillin zone diameters ≤ 19 mm, because zones ≤ 19 mm occur
with penicillin-resistant, -intermediate, or certain -susceptible strains.
14 For
CSF isolates, report only meningitis interpretations. For
all isolates other than those from CSF, report interpretations for both
meningitis and nonmeningitis.
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ANNEX
B:
REPORT ON GROUPS AND COLLECTION OF MONTHLY CULTURE DATA
Following data shall be
inputted in Data Entry section of the AMR website: kks.kcb.vn; details
about data requirements serving data provision shall be specified in this
Annex. Testing laboratories shall receive additional instruction on
how to send this data to the website.
Annual reports on data of
patient groups
. The data shall be reported
once a year and must be submitted before January 31 of the following year (e.g.
data of 2019 must be reported before January 31, 2020).
- Reporting
year (e.g. “2019”)
- Total
number of beds a hospital in the reporting year
- Total
number of inpatients in the reporting year
- Total
number of outpatients in the reporting year
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. Only mandatory for testing
laboratories that fail to report and attach monthly negative culture data in
the WHONET file.
. For each type of specimen:
report the total positive and negative culture of each month.
. Deadline for report
submission: before the 10th of the following month (e.g. data from January 1,
2019 to January 31, 2019 shall be uploaded on the website kks.kcb.vn before
February 10, 2019).
Specimens
Bacteria prioritized for
surveillance
Blood
E. coli
K. pneumoniae
A. baumannii
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S. pneumoniae
Salmonella spp.
Urine
E. coli
K. pneumoniae
Stool
Salmonella spp.
Shigella spp
Urethra and vaginal
discharge
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Specimens from other
sterile parts of the body
Cerebrospinal fluid
Fluid in joints
Fluid in hip joint
Pleural effusion
Pericardial fluid
Synovial fluid
Peritoneal cavity fluid
Pus from abscess
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Acinetobacter spp.
Escherichia coli
Enterococcus spp.
Klebsiella spp.
Pseudomonas spp.
Staphylococcus aureus
Streptococcus pneumoniae
ANNEX
C:
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1. Introduction
This document aims to
instruct testing laboratories to submit microbiology data (following WHONET
format) to the AMR website of Vietnam Administration of Medical Services –
Ministry of Health. The document includes detailed step-by-step instruction on
how to submit a WHONET file and data on total number of specimens each month,
and how to check responses of experts on computer files.
2. Log
in
Username: Will be provided
for each testing laboratory
Password: Will be provided
for each testing laboratory
User: Employees of the
testing laboratories shall directly submit the reports
Web browser: Chrome, Firefox
Reporting address: http://kks.kcb.vn
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3. Interface
After successful login, the
first interface will appear
The interface shall display
information on completion level of the monthly data as well as evaluation and
responses from data inspection teams.
4. Report
production and submission
Step 1: Click “Submit file”
(“Gui file”) at the bottom of the screen
Step 2: Choose “Table”
(“Bieu nhap”) and date
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Step 4: Wait until the file
is sent successfully and the “file” box turns green.
Step 5: Enter number of
specimens on a monthly basis (Only required for testing laboratories which do
not have data on negative testing results in the WHONET file)
Step 6: Click “Finish”
(“Hoan thanh”)
