2018, AMR Surveillance SOPncdc.gov.in/WriteReadData/l892s/...4. External Quality Assessment SOP (to...

Standard Operating Procedures (SOP)

Surveillance of Priority Bacterial Pathogens under

National AMR Surveillance Network

National Programme for Containment of Antimicrobial Resistance National Centre for Disease Control, India

February 2019

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Contents Summary .......................................................................................................................................................................... 4

Pathogens and specimens included under AMR surveillance ......................................................................................... 4

Standard bacteriology and antimicrobial susceptibility testing methods ....................................................................... 6

Internal quality control .................................................................................................................................................... 7

External quality assessment ............................................................................................................................................ 8

Surveillance AST panels ................................................................................................................................................... 8

Mandatory clinical and epidemiological details of each isolate reported to NCDC ........................................................ 8

Data de-duplication of priority pathogen isolate data .................................................................................................... 9

Acceptable data formats for submission to NCDC ........................................................................................................ 10

Frequency of data submission to NCDC ........................................................................................................................ 10

Alerts for reporting resistance patterns of public health concern ................................................................................ 11

Annex 1: National AMR Surveillance Network AST Panels ........................................................................................... 12

Annex 2: Suggested Additional Clinical AST Panels ....................................................................................................... 15

Annex 3: Alert Form for Reporting Emerging AMR Resistance of Public Health Concern ............................................ 17

Annex 4: Unique laboratory codes for AMR data reporting to NCDC using WHONET ................................................. 19

Annex 5: List of priority pathogen code for data entry in WHONET ............................................................................. 20

Annex 6: Antibiotic codes for surveillance data entry in WHONET............................................................................... 21

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Summary This guidance document defines the standards for antimicrobial susceptibility testing (AST), data collection, and

reporting processes for sites participating in the Antimicrobial Resistance (AMR) Surveillance Network

coordinated by the National Centre for Disease Control, India (NCDC). It provides guidelines to ensure consistent

AST procedures and systematic AMR surveillance data reporting from sites across the network. At the site level,

the analysis of AMR surveillance data should be used for the development of traditional and enhanced

institutional antibiograms and guide clinicians for antibiotic treatment options.

Data submitted to NCDC from each of the surveillance network sites will be used at the national level to

characterize the AMR scenario across the country and provide guidance for policy and practice. As the

designated national coordinating centre for AMR surveillance by the Ministry of Health and Family Welfare,

NCDCwill report aggregated AMR surveillance data to the Global Antimicrobial Surveillance System (GLASS) to

contribute towards global understanding of the AMR public health threat.

This document covers the following:

1. Pathogens and clinical specimens included under National AMR Surveillance

2. Standard bacteriology and antimicrobial susceptibility testing procedures to be performed (to be

provided)

3. Internal Quality Control (IQC) standards (to be provided)

4. External Quality Assessment SOP (to be provided)

5. Mandatory details of each isolate recorded and reported to NCDC

6. Standard formats for data submission to NCDC

7. Frequency of data submission to NCDC

8. Annex 1: Standard AST panels for each pathogen and specimen type under surveillance

9. Annex 2: Suggested additional AST Panels for clinical reporting

10. Annex 3: Alert form for reporting resistance patterns of public health concern

11. Annex 4: Unique laboratory codes for AMR data reporting to NCDC using WHONET

12. Annex 5:List of priority pathogen code for data entry in WHONET

13. Annex 6: Antibiotic codes for surveillance data entry in WHONET

Pathogens and specimens included under AMR surveillance

The national AMR Surveillance Network at NCDC prioritizes the following pathogens for AMR surveillance:

1. Enterococcus species

2. Staphylococcus aureus

3. Escherichia coli

4. Klebsiella species

5. Acinetobacter species

6. Pseudomonas species

7. Salmonella enterica, serotypes Typhi and Paratyphi

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Five clinical specimens are included in AMR surveillance: blood, urine, pus aspirate, other sterile body fluid, and stool. Details on case definitions for each of the clinical specimens and the relevant organisms are as follows Table 1: Clinical specimens included in AMR surveillance

Clinical Specimen Laboratory case-definition Organisms under Surveillance

Blood Isolation of pathogen from blood Enterococcus species Staphylococcus aureus Escherichia coli Klebsiella species Acinetobacterspecies Pseudomonas species Salmonella enterica Typhi Salmonella enterica Paratyphi

Urine1 Clinically significant bacteriuria* Enterococcus species Escherichia coli Klebsiella species Acinetobacter species Pseudomonas species

Pus Aspirate2 Significant growth from aspiration of purulent material from a closed infected site

Enterococcus species Staphylococcus aureus Escherichia coli Klebsiella species Acinetobacter species Pseudomonas species

Other Sterile Body Fluid3

Significant growth from a sterile body fluid specimens (CSF, pleural fluid, peritoneal fluid, synovial fluid, pericardial fluid)

Enterococcus species Staphylococcus aureus Escherichia coli Klebsiella species Acinetobacter species Pseudomonas species

Stool Isolation of pathogen from stool Salmonella enterica Typhi Salmonella enterica Paratyphi

1. Interpret urine cultures in conjunction with clinical symptoms of UTI (such as dysuria, urinary frequency,

suprapubic pain, flank pain, and fever). Avoid reporting mixed bacterial growths or samples collected

from urine bags.For clean-catch (or mid-stream) urine samples:

a. Bacterial growth of >100,000 (>105) organisms or colony forming units (CFU)/mL is suggestive of

urinary tract infection (UTI)*

b. Growth of 1,000 – 100,000 CFUs/mL (103 – 105 CFU/mL) may indicate UTI in

i. Patients with pyelonephritis, prostatitis, epididymitis or fungal infections, or samples

collected on cystoscopy or other invasive procedures

ii. Correlate bacteriuria with presence of pyuria (>10 pus cells/micro Litre) and absence of

squamous epithelial cells for true infections

2. Pus aspirate include aspiration of purulent material from a closed infected site only. Pus “swabs” and

“wound swabs” should not be included in AMR surveillance reporting.

3. Other sterile body fluids include cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid (ascites),

synovial fluid, and pericardial fluid.

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Sites participating in the NCDC AMR Surveillance Network should test and report information on pathogens by

type of clinical specimen as outlined in Table 2 below.

Table 2: Pathogens under AMR surveillance, by specimen type

Standard bacteriology and antimicrobial susceptibility testing methods Isolation, identification and antimicrobial susceptibility testing (AST) should be performed according to

bacteriology standard operating procedures (SOPs) developed under the National AMR surveillance programme

(to be provided)

Antibiotic susceptibility testing done in the labs may contain the panel of antibiotics based on local clinical

prescription practices, however the discs mentioned in the surveillance SOPs (Annexure 1) should be used

mandatorily while performing AST for routine testing.

Network laboratories using automated culture (BACTEC, BacT/ALERT systems), ID and AST machines (VITEK,

Microscan, BD Phoenix etc.) are advised to perform the tests and quality control following standard operating

procedures as indicated in the user manual.

Organism Type of Clinical Specimen

Enterococcus species

Blood

Urine

Pus aspirate

Other sterile body fluid

Staphylococcus aureus Blood

Pus aspirate


Escherichia coli Blood

Urine

Pus aspirate


Klebsiella species Blood

Urine

Pus aspirate


Acinetobacter species

Blood

Urine

Pus aspirate


Pseudomonas species Blood

Urine

Pus aspirate


Salmonella enterica serotypes Typhi and Paratyphi Blood

Stool

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AST methods

Antimicrobial susceptibility testing of pathogens under surveillance can be done either by manual or automated

methods

I. Manual AST Methods

1. Kirby Bauer Disc Diffusion: For the majority of reported isolates, AST is performed using the Kirby-Bauer

disk diffusion method. Results for disk diffusion AST should be reported as zone inhibition diameters

only. Each zone diameter should be clearly measurable. Overlapping zones prevent accurate

measurement. Measure the diameter of the zones of complete inhibition including the diameter of the

disk. Hold the Petri plate a few inches above a black background illuminated with reflected light, except

for linezolid. For Linezolid AST, zone should be examined using transmitted light (plate held up to light

source). Organisms that test resistant should be confirmed by MIC values either by broth microdilution

or by using automated AST system MIC.

2. Exceptions for disk diffusion are AST of Colistin in gram negatives and Vancomycin in Staphylococcus

aureus isolates. Both sould be done by using broth microdilution and not by disc diffusion

3. Screen Agar: AST for vancomycin in Staphylococcus aureus requires testing by vancomycin screen agar.

Results should be reported as MIC (<8 µg/mL, or ≥8µg/mL). MIC values ≥8µg/mL should be reported to

the reference laboratory at NCDC/laboratory identified by NCDC.

AST for vancomycin for Enterococcus species can be performed by disc diffusion.

AST for vancomycin in Staphylococcus aureus should reported only if the lab has confirmed it using MIC

4. Broth micro dilution:

a. AST for Colistin in all isolates of E. coli, Klebsiella species, Acinetobacter species, and Pseudomonas

aeruginosa requires testing by broth microdilution. Results should be reported as minimum

inhibitory concentration (MIC) breakpoint.

b. AST for vancomycin in all isolates of S. aureus in which growth has been detected (MIC ≥8µg/mL) on

vancomycin screen agar requires repeat AST testing by broth microdilution. Results should be reported

as MIC breakpoint.

II. Automated AST systems (Vitek2, Phoenix, Microscan): If a facility performs AST using an automated AST

system, results should be reported as MIC breakpoints for all pathogen-antibiotic (i.e. “bug-drug”)

combinations tested. If AST by BOTH manual disc diffusion and automated testing methods are performed,

MIC results should be reported. AST results of Colistin should not be reported if performed by an

automated system (CLSI 2019 M 100 S 29)

Internal quality control All participating laboratories are expected to routinely perform standard Internal Quality Control (IQC) for AST

utilizing ATCC strains. This includes IQC for culture media as well as antibiotic discs used in AST. For reference to

IQC standards NCDC through CDC has provided/ will be providing CLSI Guidelines M100, M02, M07 to all the

AMR surveillance network sites. To facilitate the quality control NCDC has supplied/ will be supplying select

ATCC strains to all the sites. IQC guidance document will be provided by NCDC in January 2019.

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External quality assessment 1. To ensure quality of results, all participating laboratories are expected to submit 1% of isolates for each

pathogens per surveillance program directives to NCDC every QUARTER for confirmatory testing.

Instructions for storing and sharing the isolates will be provided.

2. Each participating site is expected to be enrolled in the Microbiology/Bacteriology External Quality

Assessment Scheme (EQAS) conducted by the Indian Association of Medical Microbiology (IAMM).

3. Sites are expected to share the results of IAMM EQAS panels with NCDC annually. Sites are expected to

maintain a score of at least 80% in EQAS identification/susceptibility for a minimum of 3 out of 4

quarters in a year.

4. NCDC will facilitate enrollment for sites to a tier 2 AMR specific EQAS for the sites which are already

participating in IAMM EQAS.

Surveillance AST panels Pathogen specific surveillance AST panels have been outlined by NCDC in Annex 1: NCDC AMR Surveillance AST

Panels (Page 12).

AST for these specific pathogen – antibiotic combinations is considered a priority for public health and

surveillance. This list is not exhaustive for all antibiotics that may be tested for clinical purposes.

It is critical that AST is performed and reported for ALL the listed antibiotics in the surveillance AST panel

on every isolate of the pathogens and clinical sample types under surveillance. This is essential to

ensure that surveillance results are a valid representation of the facilities in the network.

While the antibiotics listed in the surveillance AST panels are critical for public health purposes,

microbiology laboratories may wish to perform AST for additional antibiotics to guide clinical decision

making. Suggested additional clinical AST panels for each pathogen and clinical sample type under

surveillance are included in Annex 2: Suggested Additional Clinical AST Panels(Page 15) or panels as

recommended by CLSI 2018

In contrast to AST surveillance reporting to NCDC, reporting of AST results to clinicians at the facility

level may be selective to promote appropriate and rational antibiotic use. For example, for an isolate

collected from specimen in the out-patient setting that is sensitive to all or most oral antibiotic options,

the site may choose to restrict clinical reporting of AST results for injectable antibiotics. These decisions

can be made at the facility level.

Mandatory clinical and epidemiological details of each isolate reported to NCDC The following demographic and clinical data fields must be included in the reporting format: All the variables are

mandatory for data entry and attempts should be made to collect the details of the patients including district of

their residence. Village/ locality details are optional if available can be entered otherwise you may mention - NA

a. Hospital Code: Each hospital will be assigned a three-letter hospital ID code. The configured

WHONET file sent to your institute will be pre-populated with this specific hospital code.

b. Patient ID: Patient’s unique Hospital ID.

c. Specimen ID: Laboratory ID assigned to the specific clinical sample. If culture/AST is performed

on multiple clinical samples from the same patients, there may be multiple laboratory specimen

ID’s associated with a single Patient ID.

d. State: State of patient's residence

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e. District: District of patient’s residence

f. Village/Locality: (Optional)

i. Village of patient’s residence for rural patients

ii. Locality of patient’s residence for urban patients

g. Age in Years:

i. For age 12 months and older. Age in years rounded to nearest whole year (1, 2, 3…)

ii. For infants l1month to 11 months of age, enter the age in months (1m, 2m, 3m,….11m)

iii. For neonates less than 1 week (1-6 days of age, enter age in days. The date of birth

should be taken as 1 day (1d, 2d, 3d,…6d)

iv. For neonates more than 1 week and less than 28 days, enter (1w, 2w,3w,4w)

h. Sex: Male, Female, or Other

i. Date of Admission: In DD/MM/YYYY format, the date the patient was admitted to the reporting

health facility. Every attempt should be made to record date of admission of all in patients. If

date of admission is not available, leave this field blank, but do NOT remove the field from your

reporting format.

j. Patient Location: Ward number, OPD number, ICU type in the hopital where the clinical

specimen was collected from patients.

k. Patient Location Type: Classify if specimen is taken from a patient seen in the intensive care unit

(icu), inpatient department (in), or outpatient department (out). Standard WHONET codes will

be used while entering these details so that location type-wise antibiograms may be generated.

Every attempt should be made to record the hospital location of the patient and department

under which the patient was admitted from whom the specimen is taken.

l. Specimen collection date: In DD/MM/YYYY format, the date the specific clinical sample was

collected from the patient.

m. Specimen type: Classify type of clinical sample—blood, urine, pus aspirate, other sterile body

fluid, stool

n. Pathogen isolated: Classify priority pathogen isolated: Enterococcus species, S. aureus, E. coli,

Klebsiella species, Acinetobacter species, Pseudomonas species, Salmonella enterica Typhi,

Salmonella enterica Paratyphi

o. AST results to be reported in the following acceptable formats for each antibiotic designated in

the surveillance AST panel for each organism/specimen type:

i. Disc Diffusion: Zone inhibition diameter (in mm)

ii. Broth microdilution: MIC breakpoint (in µg/mL)

iii. Screen Agar (for Vancomycin): MIC(<8µg/mL or ≥8µg/mL)

iv. Automated AST results: MIC breakpoint (in µg/mL)

Data de-duplication of priority pathogen isolate data

During the data analysis at NCDC, data de duplication will be done on isolate data received from network

laboratories using WHONET. Deduplication will be done to achieve one isolate per patient. When several clinical

specimens are collected during patient management at the reporting facility, duplicate findings for the same

patient will be excluded (de-duplication) for surveillance purposes. For each surveillance period, only one AST

result i.e. result of the first isolate reported from the same patient during the hospital stay for each patient per

surveyed specimen type and surveyed pathogen.

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For example if two blood cultures from the same patient yield growth of E. coli, only the first result will be

included in the data analysis and report ; if growth of E. coli detected in one culture and of K. pneumoniae in the

other, both results will be analyzed and reported. If there is growth of E. coli in one blood culture and in one

urinary culture from the same patient, both specimen types will be analyzed and reported. If possible, repeated

negative results for the same specimen type in the same patient should also be de-duplicated at the facility

level. [Source: WHO Global Antimicrobial Surveillance System Manual for Early Implementation (2015)].

Data de-duplication is primarily performed using WHONET at the facility level before creating antibiograms

NCDC will provide technical support to sites on this process.

Acceptable data formats for submission to NCDC Data should be submitted in either of the following two formats. The preferred method of data submission to

NCDC is in a WHONET data file.

1. Standard WHONET file (PREFERRED)

i. NCDC will send a pre-configured WHONET file to each of the participating surveillance network

sites. Sites who are not using WHONET already, should use this pre-configured file for entering

and reporting AMR surveillance data. For the labs already using WHONET for their regular lab

data reporting, need to run NCDC reporting configuration file against their lab data file.

ii. The pre-configured file includes specific Bug-Drug combinations used for surveillance purpose.

Data entry can be directly done into WHONET by using this configuration. Without deleting /

modifying the existing variables, sites may add additional variables in this configuration

including additional antibiotics used as per their local requirements. This data can be directly

exported to NCDC format later using the data export guidance manual by NCDC for AMR

surveillance quarterly reporting OR

iii. Data imported to WHONET from hospital Excel/lab information system using Backlink.

iv. NCDC and CDC will provide technical support to sites to configure their systems to support data

importation from automated/hospital information system/Excel to WHONET.

2. NCDC provided Excel format (ALTERNATE OPTION, if WHONET not possible currently)

i. The Excel format has been pre-configured for each site to include the pre-populated Hospital

code will be sent only on request by the network lab

ii. Enter data in the Excel format following the directions listed in the first tab of the Excel

workbook. Certain fields have limited options that may be entered using the drop-down menus.

iii. Do NOT modify this format.

iv. Excel based entry is only a temporary measure and NCDC recommends all AMR surveillance

sites to migrate to WHONET 2018 based data entry or data import at the earliest

Frequency of data submission to NCDC

Data should be submitted to NCDC every THREE months

o Data from January 1 to March 31 of the current year should be submitted by APRIL 15

o Data from April 1 to June 30 of the current year should be submitted by JULY 15

o Data from July 1 to September 30 of the current year should be submitted by OCTOBER 15

o Data from October 1 to December 31 of the previous year should be submitted by JANUARY 15

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Alerts for reporting resistance patterns of public health concern

When certain resistance patterns are detected, an alert should be sent to NCDC within ONE WEEK of

detection using the duly filled attached “Alert Form for Concerning Resistance Patterns” (Annex 3). The

form should be submitted via email to [email protected]

The suspected AMR pattern should be reported to NCDC along with the resistant ISOLATE for

confirmation within a week, NCDC will coordinate confirmatory AST.

Detection of the following prioritized resistance patterns that should prompt an ALERT notification to

NCDC

1. Vancomycin intermediate susceptibility (VISA) or vancomycin resistance (VRSA)in S.aureus (I:

MIC 4-8µg/mL, R: MIC ≥ 16µg/mL)

2. Colistin resistant E. coli, Klebsiella species, Acinetobacter species, or Pseudomonas

aeruginosa(MIC > 2µg/mL)

3. Linezolid resistant gram positive cocci

Staphylococcus aureus: R: MIC ≥ 8µg/mL, Zone ≤ 20 mm; MIC preferred

Enterococcus species: R: MIC ≥ 8µg/mL, Zone ≤ 20 mm

4. Ceftriaxone or Azithromycin resistant Salmonella enterica serotype Typhi and Paratyphi

5. Ceftriaxone intermediate sensitive Salmonella enterica serotype Typhi and Paratyphi

6. Imipenem resistant Salmonella enterica serotype Typhi and Paratyphi

7. Any other significant drug resistant pathogen

Data validation, consistency check and feedback will be provided by NCDC within 15 days of submitting your

quarterly data in prescribed WHONET format.

For AMR data analysis at the facility level, Please refer to WHONET 2018 data analysis SOP by National AMR

Surveillance Network, NCDC.

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Annex 1: National AMR Surveillance Network AST Panels

*Zone should be examined using transmitted light. Resistant organisms by disk diffusion should be confirmed by MIC

Staphylococcus aureus – AMR Surveillance AST Panel

BLOOD, PUS ASPIRATE, OTHER STERILE BODY FLUID

Gentamicin 10 μg

Ciprofloxacin 5 μg

Erythromycin 15 μg

Trimethoprim Sulfamethoxazole

(TMP/SMX) i.e. Co-trimoxazole 1.25/23.75 μg

Cefoxitin 30 μg

Doxycycline 30 μg

Clindamycin 2 μg

Vancomycin** screen agar

Linezolid* 30 μg

**If positive growth is detected on Vancomycin screen agar, perform Vancomycin AST by broth micro dilution *Linezolid zone should be examined using transmitted light. Resistant organisms by disk diffusion should be confirmed by MIC

Escherichia coli – AMR Surveillance AST Panel

BLOOD, PUS ASPIRATE, OTHER STERILE

BODY FLUID

URINE

Ampicillin 10 μg Ampicillin 10 μg

Ciprofloxacin 5 μg Ciprofloxacin 5 μg

TMP/SMX* 1.25/23.75 μg TMP/SMX* 1.25/23.75 μg

Cefotaxime 30 μg Cefotaxime 30 μg

Cefepime 30 μg Cefepime 30 μg

Imipenem 10 μg Imipenem 10 μg

Colistin** MIC Nitrofurantoin 300 μg

*TMP/SMX= Trimethoprim Sulfamethoxazole (i.e. Co-trimoxazole)

**AST for Colistin should be performed by broth microdilution on all blood and other sterile body fluid isolates

Enterococcus species – AMR Surveillance AST Panel


BODY FLUID

URINE


Gentamicin (high level) 120 μg Gentamicin (high level) 120 μg

Erythromycin 15 μg Ciprofloxacin 5 μg

Doxycycline 30 μg Tetracycline 30 μg

Vancomycin* 30 μg Vancomycin 30 μg

Linezolid* 30 μg Linezolid* 30 μg

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**AST for Colistin should be performed by broth micro dilution for all blood and other sterile body fluid isolates

Acinetobacter species – AMR Surveillance AST Panel

BLOOD, PUS ASPIRATE, OTHER STERILE BODY FLUID, URINE

Amikacin 30 μg

Gentamicin 10 μg

Ciprofloxacin 5 μg

Piperacillin Tazobactam 100/10 μg

Ceftazidime 30 μg

Imipenem 10 μg

Minocycline 30 μg

Colistin* MIC

*AST for Colistin should be performed by broth microdilution for all blood and other sterile body fluid isolates

Pseudomonas species – AMR Surveillance AST Panel

BLOOD, PUS ASPIRATE, OTHER STERILE BODY FLUID, URINE

Amikacin 30 μg

Gentamicin 10 μg

Ciprofloxacin 5 μg

Piperacillin- Tazobactam 100/10 μg

Ceftazidime 30 μg

Imipenem 10 μg

Colistin* MIC

*AST for Colistin should be performed by broth micro dilution for all blood and other sterile body fluid isolates

Klebsiella species – AMR Surveillance AST Panel

BLOOD, URINE, PUS ASPIRATE, OTHER STERILE BODY FLUID

Ciprofloxacin 5 μg

TMP/SMX* 1.25/23.75 μg

Cefotaxime 30 μg

Cefepime 30 μg

Imipenem 10 μg

Colistin** MIC

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Salmonella enterica Serotypes Typhi and Paratyphi – AMR Surveillance AST Panel

Blood Stool **


Ciprofloxacin 5 μg Ciprofloxacin 5 μg

TMP/SMX 1.25/23.75 μg TMP/SMX 1.25/23.75 μg

Chloramphenicol 30 μg Chloramphenicol 30 μg

Ceftriaxone 30 μg Ceftriaxone 30 μg

Imipenem* 10 μg Imipenem 10 μg

Azithromycin*# 15 μg

# AST for Azithromycin should be performed only on isolates of S. Typhi

*For Salmonella Typhi and Paratyphi blood Isolates, do not report Imipenem and Azithromycin AST results to clinicians unless there is resistance/ intermediate sensitivity observed for 3rd generation Cephalosporin.

However, complete panel of antibiotics to be reported to NCDC for surveillance purposes.

**For intestinal isolates of S. Typhi, CLSI recommends only the following for routine reporting:

1. Ampicillin

2. Fluoroquinolone

3. TMP/SMX

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Annex 2: Suggested Additional Clinical AST Panels The tables below lists additional antibiotics that may be included in AST for each of the organisms and clinical

sample types under surveillance. Reporting AST results to clinicians at the facility may be selective (ie not all

results for all antibiotics are reported) to support appropriate and rational antibiotic use. This is particularly

relevant for reporting AST results for ‘reserve’ antibiotics (e.g. Fosfomycin). Laboratories may choose to report

susceptibility of ‘reserve’ antibiotics when the isolate appears resistant to other last resort antibiotics.

Escherichia coli – Suggested Additional CLINICAL AST Panel

BLOOD URINE PUS ASPIRATE/OTHER STERILE

BODY FLUID

Amoxicillin-

clavulanate 20/10 μg Amoxicillin-


clavulanate 20/10 μg

Piperacillin-tazobactam 100/10 μg Piperacillin-

tazobactam 100/10 μg Piperacillin-

tazobactam 100/10 μg

Ertapenem 10 μg Cefuroxime 30 μg Ertapenem 10 μg

Meropenem 10 μg Ertapenem 10 μg Meropenem 10 μg

Amikacin 30 μg Meropenem 10 μg Amikacin 30 μg

Gentamicin 10 μg Amikacin 30 μg Gentamicin 10 μg

Fosfomycin 200 μg Doxycycline 30 μg

Klebsiella species – Suggested Additional CLINICAL AST Panel

BLOOD URINE PUS ASPIRATE/OTHER STERILE

BODY FLUID

Amoxicillin-clavulanate 20/10 μg Amoxicillin-


clavulanate 20/10 μg

Piperacillin-tazobactam 100/10 μg Piperacillin-

tazobactam 100/10 μg Piperacillin-

tazobactam 100/10 μg

Imipenem 10 μg Cefuroxime 30 μg Ertapenem 10 μg

Meropenem 10 μg Ertapenem 10 μg Meropenem 10 μg

Amikacin 30 μg Meropenem 10 μg Amikacin 30 μg

Gentamicin 10 μg Amikacin 30 μg Gentamicin 10 μg

Nitrofurantoin 300μg Doxycycline 30 μg

Enterococcus species – Suggested Additional CLINICAL AST Panel


BODY FLUID

URINE

Teicoplanin 30 μg Teicoplanin 30 μg

Fosfomycin 200 μg

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Staphylococcus aureus – Suggested Additional CLINICAL AST Panel

BLOOD PUS ASPIRATE/OTHER STERILE BODY FLUID

Teicoplanin MIC Teicoplanin MIC

Pseudomonas species– Suggested Additional CLINICAL AST Panel


Aztreonam 30 μg

Meropenem 10 μg

Netilmicin 30 μg

Acinetobacter species– Suggested Additional CLINICAL AST Panel


Meropenem 10 μg

Cefotaxime 30 μg

TMP/SMX* 1.25/23.75 μg


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Annex 3: Alert Form for Reporting Emerging AMR Resistance of Public Health

Concern

A. Laboratory Information

1.Name of the reporting laboratory: 2.Name and Contact Information of Microbiologist:

B. Patient Demographic Information

3.Patient ID: 4.Specimen ID:

5.Completed Age (in years/ month/ week/days):

6. Sex (Tick one box): Male ☐ Female ☐ Other ☐

7.District: 8.Village (rural) / Locality (urban):

C. Admission Information

9. Date of Hospital Admission

D D M M Y Y Y Y

10. Location of patient at the time of sample collection

(Tick one box) ICU☐ IPD ☐ OPD☐ Other ☐

D. Specimen Type and Pathogen Isolated

11. Specimen Collection Date Click here to enter a date. D D M M Y Y Y Y

12. Type of Specimen (Tick one box) 13.Isolated Pathogen (Tick one box)

a. Blood ☐

b. Urine ☐

c. Stool☐

d. Pleural Fluid ☐

e. CSF☐

f. Pus Aspirate☐(specify location:___________)

g. Other Sterile Body Fluid ☐(specify:______) \

1. Staphylococcus aureus ☐

2. Escherichia coli☐

3. Klebsiella species ☐specify species if known:

4. Acinetobacter species ☐specify species if known

5. Pseudomonas species ☐specify species if known

6. Enterococcus species ☐ specify species if known:

7. Salmonella enterica ☐specify serotype if known

E. Detected/ Suspected Resistance Pattern F. Method of Detection(Tick all that apply) G. AST details

1. Suspected VISA (Vancomycin Intermediate S. aureus)

☐Growth on Vancomycin Screen Agar

☐MIC 4-8 μg/ml by automated AST

☐MIC 4-8 μg/ml by broth microdilution

2. Suspected VRSA (Vancomycin Resistant S. aureus)

☐Growth on Vancomycin Screen Agar

☐MIC ≥ 16μg/ml by automated AST

☐MIC ≥ 16 μg/ml by broth microdilution

3. Suspected Colistin resistance (Enterobacteriaceae & Non fermenters)

☐MIC > 2 μg/ml by broth microdilution

4. Suspected Linezolid resistance (in VREs and S. aureus)

(When testing linezolid using disk diffusion, zones should be examined using transmitted light. Organisms with resistant results by disk diffusion should be confirmed using MIC method)

☐ Zone diameter ≤ 20 mm by disc diffusion

☐MIC ≥ 8 μg/ml by automated AST


5. Suspected Ceftriaxone resistance in Salmonella enterica serovar Typhi



☐MIC ≥ 4μg/ml by broth microdilution

6. Suspected ceftriaxone intermediate sensitivity in Salmonella enterica serovar Typhi

☐ Zone diameter 20-22 mm disc diffusion

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7. Suspected Azithromycin resistance in Salmonella enterica serovar Typhi


☐MIC ≥ 32 μg/ml by automated AST


8. Suspected Imipenem or Meropenem resistant Salmonella enterica serovar Typhi



☐MIC ≥ 4μg/ml by broth microdilution

9. Other significant resistance Pathogen: (If other than listed in E. 8) Drug 1:___________________ Drug 2.___________________ Drug 3: ___________________ Drug 4: ___________________

Drug 1: ☐ Zone diameter ____ by disc diffusion

☐MIC _____ μg/ml by automated AST

☐MIC _____ μg/ml by broth microdilution Drug 2:

☐ Zone diameter ____ by disc diffusion


☐MIC _____ μg/ml by broth microdilution Drug 3:



☐MIC _____ μg/ml by broth microdilution

Drug 4:



☐MIC _____ μg/ml by broth microdilution

H. Clinical Notes

Date of Reporting: Reported by:

(Name, signature & seal)

19

Annex 4: Unique laboratory codes for AMR data reporting to NCDC using WHONET

Sl No

Lab Code Data Entry State NCDC AMR Network Laboratory

Lab code for reporting to NCDC

1 BJA Gujarat BJ Medical College, New Civil Hospital, Haripura, Asarwa, Ahmedabad- 380016

N01

2 BJP Maharashtra B.J. Govt. Medical College and Sassoon General Hospitals, Jai Prakash Narayan Road, Near Pune Railway Station, Pune –411001

N02

3 CHG Chandigarh Government Medical College, Sarai Building, Sector 32c, Chandigarh. 160017

N03

4 KAN Uttar Pradesh Ganesh Shankar Vidyarthi Memorial Medical College Swaroop Nagar, Kanpur- 208002

N04

5 LHM Delhi Lady Hardinge Medical College, C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, DELHI 110001

N05

6 MMC Karnataka Mysore Medical College and Research Institute, Irwin Road, Next to Railway Station, Mysore 570001

N06

7 SMS Rajasthan Sawai Man Singh Medical College Medical College (SMS )Medical College, J.L.N. Marg, Jaipur - 302004

N07

8 SFD Delhi Vardhman Mahavir Medical College Building Safdarjung Hospital, Ansari Nagar, New Delhi -110029

N08

9 GMC Kerala Government Medical College, Thiruvananthapuram - 695011

N09

10 KML Tamil Nadu KAPV Government Medical College, Periyamilaguparai, Colletor's office Road, Trichy- 620001, Tamil Nadu

N10

11 GMA Assam Gauhati Medical college, GMCH Complex, GMC Hospital Rd, Bhangagarh, GUWAHATI - 781032

N11

12 NIG Meghalaya North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIMS) Mawdiangdiang, Shillong -793018

N12

13 MGI Madhya Pradesh Mahatma Gandhi Memorial Medical College, A.B.Road, Near M.Y.Hospital, INDORE - 452001

N13

14 IGS Himachal Pradesh Indira Gandhi Medical College (IGMS), Circular Road, Lakkar Bazar, SHIMLA - 171001

N14

15 AUG Maharashtra GMC, Aurangabad, Panchakki Road, near Jubli Park Chowk, Aurangabad-431001, Maharashtra

N15

20

16 OSM Telengana Osmania Medical College 5-1-890, Turrezbaz Khan Road, Koti, Hyderabad-500012

N16

17 GNT Andhra Pradesh Guntur Medical College, Guntur-522004 N17

18 AGA Tripura AGMC & GBP Hospital, P.O. Kunjauan, Agartala-799006, Tripura (West)

N18

19 CTC Odisha SCB Medical College, Mangalabag-753007, Cuttack, Odisha

N19

20 JMU Jammu & Kashmir Government Medical College and Hospital, Department of Microbiology, Bakshi nagar, Jammu (J&K)

N20

Annex 5: List of priority pathogen code for data entry in WHONET

Priority Pathogen WHONET code

Enterococcus species ENT

Staphylococcus aureus SAU

Escherichia coli ECO

Klebsiella species KL-

Acinetobacter species AC-

Pseudomonas species PS-

Salmonella enterica Serotype Typhi SAT

Salmonella enterica Serotype Paratyphi PTY

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Annex 6: Antibiotic codes for surveillance data entry in WHONET

Antibiotic WHONET code Measurement

Amikacin 30 μg AMK Disk

Ampicillin 10 μg AMP Disk

Azithromycin 15 μg AZM Disk

Aztreonam 30 μg ATM Disk

Cefepime 30 μg FEP Disk

Cefotaxime 30 μg CTX Disk

Cefoxitin 30 μg FOX Disk

Ceftazidime 30 μg CAZ Disk

Ceftriaxone 30 μg CRO Disk

Chloramphenicol 30 μg CHL Disk

Ciprofloxacin 5 μg CIP Disk

Clindamycin 2 μg CLI Disk

Doxycycline 30 μg DOX Disk

Erythromycin 15μg ERY Disk

Ertapenem 10 μg ETP Disk

Gentamicin 10 μg GEN Disk

Gentamicin High 120 μg GEH Disk

Imipenem 10 μg IMP Disk

Linezolid 30 μg LNZ Disk

Meropenem 10 μg MEM Disk

Minocycline 30 μg MNO Disk

Netilmicin 30 μg NET Disk

Nitrofurantoin 300 μg NIT Disk

Piperacillin/Tazobactum 100/10 μg TZP Disk

Tetracycline 30μg TCY Disk

Tobramycin 10 μg TOB Disk

Teicoplanin 30μg TEC Disk

Trimethoprim/ Sulfamethoxazole 1.25/23.75 μg SXT Disk

Vancomycin 30μg VAN Disk

Colistin COL MIC

Fosfomycin FOS MIC

Teicoplanin TEC MIC

Vancomycin VAN MIC

Annex 7- 12 will be provided separately through email

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