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

AST^a

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

Clindamycin^1,6

Folate antagonists

TMP/SMX (also known as Co-trimoxazole)

Glycopeptide

Vancomycin (only for MIC method)⁴.

Oxazolidinone

Linezolid

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Tetracycline^1,4 or Doxycycline^1,4 or Minocycline^1,4,6 (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

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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”)

Quyết định 127/QĐ-BYT năm 2019 về "hướng dẫn thực hiện giám sát quốc gia về kháng kháng sinh" do Bộ trưởng Bộ Y tế ban hành