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The Lancet
Opens the Pandora box Gram-negative
Enterobacteriaceae withresistance to carbapenems
conferred by New Delhimetallo--lactamase 1(NDM-1) are potentially amajor global health problem.
We investigated theprevalence of NDM-1, inmultidrug-resistantEnterobacteriaceae inIndia, Pakistan, and theUK.
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Travel makes patients
venerable The superbug called
New Delhi metallo-beta-lactamase, or
NDM-1, was identifiedin 50 people whotraveled to India orPakistan for surgeryand then returned to
the United Kingdom,British scientistsreported in the journalLancet InfectiousDiseases
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Naming the strain as New Delhi
creates controversy
The gene was named after New Delhi, the capitalcity of India, as it was first described by Yong et al. in2009 in a Swedish national who fell ill with an antibiotic-resistant bacterial infection that he acquired in India . Theinfection was unsuccessfully treated in a New Delhihospital and after the patient's repatriation to Sweden, acarbapenem-resistantKlebsiella pneumoniaestrain
bearing the novel gene was identified. The presentingauthors concluded that the new resistance mechanism"clearly arose in India, but there are few data arising fromIndia to suggest how widespread it is."
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Bugs becomes Superbugs
Antibiotic resistancedevelops through geneaction or plasmid
exchange betweenbacteria of the samespecies. If a bacteriumcarries severalresistance genes, it is
called multiresistantor, informally, asuperbug.
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CDC Reports
Three Enterobacteriaceae isolatescarrying a newly describedresistance mechanism, the New
Delhi metallo-beta-lactamase(NDM-1) , were identified from
three U.S. states at the CDCantimicrobial susceptibilitylaboratory. This is the first
report of NDM-1 in the UnitedStates, and the first report ofmetallo-beta-lactamase carriageamong Enterobacteriaceae in theUnited States
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Mark Toleman of Britain's Cardiff UniversitySchool of Medicine, creates concerns ?
The inhabitants of NewDelhi are continuallybeing exposed to
multidrug-resistant andNDM 1-positivebacteria," said MarkToleman of Britain'sCardiff University
School of Medicine,who published thefindings in a study onThursday.
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Tolemans Study a Concern
to India Tolemans study, carried out
with Cardiff UniversitysTimothy Walsh and
published in The LancetInfectious Diseases journal,investigated how commonNDM 1-producing bacteriaare in community waste
seepage such as waterpools or rivulets in streets and tap water in urban NewDelhi.
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In September and October 2010, Walshs research
team collected 50 samples from public drinkingwater taps in New Delhi and 171 samples from
seepage, standing water that had pooled nearpublic areas, both of which are used by residents fordrinking, washing and/or other householdfunctions. The scientists found bacterial strains withthe NDM-1 mutation in two of the drinking water
samples and in 51 of the seepage samples. Forcomparison, they collected 70 samples from Cardiffswater supply and found no evidence of bacteria withNDM-1 mutations.
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Facts Reported on the Present
Study
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Facts on NDM-1 are Concern to
the National Health
Speech is silver
Silence is Gold
Ignoring the
facts isDangerous
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Why Microbiologists are Important
in the Changing ScenarioAdequate clinical
management ofinfectious diseases
relies primarily on theaccurate identificationof the causal micro-organism and theproduction of reliable
information on itsantimicrobialsusceptibility
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Now Clinicians Need Faster
Diagnostic Information Traditional diagnostic
methods inmicrobiology have lim-
ited the ability oflaboratories to providedoctors with timely andclinically relevantinformation, but recent
technology providesresults in minutes orhours rather than daysor weeks.
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Safety of the Laboratory Personal
A Top Priority The protection of personnel
and the immediatelaboratory environment
from exposure to infectiousagents is provided by bothgood microbiologicaltechnique and the use ofappropriate safety
equipment. The use ofvaccines may provide anincreased level of personalprotection.
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Let our Policy to start with
Containment The term "containment" is
used in describing safemethods for managinginfectious materials in the
laboratory environmentwhere they are beinghandled or maintained.The purpose ofcontainment is to reduce oreliminate exposure of
laboratory workers, otherpersons, and the outsideenvironment to potentiallyhazardous agents.
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Implementing Biosaftey at Medical
Establishments in India It is time to educate on
Biosafety issues.Document the
Information regardingthe Biosafteyequipment available inthe Hospital, Colleges,if not, to do at the
earliest, and concernsof the Health of theLaboratory personalshould be mademandatory.
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Continues to be Most Neglected part ofDiagnostic Microbiology
Can be Improved
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Endocervical swabs for GC
Per nasal swabs for pertussis
whole EMU for TB
Sputum , not saliva
Blood culture bottles, not clotted blood
Correctly timed Gentamicin assays
Pus, not swabs
Major value of the Diagnostic Microbiology islost in unscientific methods, left casually to illtrained staff
Collecting the correct specimen most neglectedpart of Diagnostic Microbiology
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Getting the specimen to the
laboratory Problems in delay or inappropriate storage delay in
diagnosis & treatment pathogens die
contaminants overgrow
Blood cultures directly into incubator not refrigerator!
CSF straight to lab Don't put an entire surgical specimen into formalin!
Send a portion to microbiology in a sterilecontainer
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Collecting the specimen correctly
Take an mid-stream urine avoids contamination with perineal flora
CSF Avoid contamination
Avoid bloody tap
Throat swab
Make the patient gag! Blood cultures Avoid contamination with skin organisms
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Labelling Specimens &
Infection Control Please be considerate to
lab staff!!
Label hazardousspecimens
Don't send specimensto the lab without
proper packing Leaking or blood-
stained specimens arenot acceptable!!!
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Factors limiting usefulness of bacteriologicalinvestigations
What is going WrongWrong sample e.g. saliva instead of sputum
Delay in transport / inappropriate storage e.g. CSF
Overgrowth by contaminants e.g. blood cultures
Insufficient sample / sampling error e.g.in mycobacterial disease
Patient has received antibiotics
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The major control on use , misuse ofAntibiotics can be controlled with Good
Practices
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The role of antimicrobial susceptibility tests to guideempirical therapy, to refine therapy once pathogens
have been isolated and identified, and to detect newtypes of antimicrobial resistance is well established.Other roles of antimicrobial susceptibility testing forpatient care, such as development of cumulativeAntibiograms, creation of antimicrobial formularies,and detection of new antimicrobial resistance strainsor trends, are also well established.
ANTIMICROBIAL
SUSCEPTIBILITY TESTING
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Quality Control on Antimicrobialtesting is crucial
Generating accurateand reproducible
antimicrobialsusceptibility test datarequires perhaps themost extensive QCprogram used in
clinical laboratoriestoday
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The CLSI publishes guidelines for the QC of
antimicrobial susceptibility tests . These guidelinesare extensive and require rigorous adherence to each
step of testing for results to be accurate andreproducible. Specific guidelines have beendeveloped not only for different categories ofbacteria and fungi (e.g., members of theEnterobacteriaceae family) but also for individual
species. Perhaps the most important guidelinespublished by CLSI are that antimicrobial agentsshould be tested against different microbialpathogens
Adherence to CLSI Guidelines ..
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The information used to develop these guidelines is based
on clinical, pharmacologic, and microbiologic data. It isstrongly recommended that clinical microbiologylaboratories and providers both adhere to theseguidelines; testing antimicrobial agentpathogencombinations that are not recommended may generateantimicrobial susceptibility test results that either aremisleading or cannot be interpreted.
In general, it is also strongly recommended that newantimicrobial agents should not be tested in clinicallaboratories until there are sufficient data for CLSIguidelines to be developed and published
Why All DiagnosticLaboratories should adhere to
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Reporting newer pattern ofResistance needs reference Methods
Detection of new types orpatterns of antimicrobialresistance may be
fortuitous or the result ofactive surveillance. Theformer should not beused to guide patient careuntil the data areconfirmed by a reference
method; publishedreports of new types orpatterns of resistancetypically reflect extensiveconfirmatory testing.
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Follow current practices as per
CLSI guidelines Most microbiology
laboratories usecommercial systems forantimicrobial
susceptibility testing,which may or may not yethave the capability ofdetecting newer forms ofresistance, reliable meansof detecting new types or
patterns of antimicrobialresistance often lagbehind publishedinformation.
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Implementation ofWHONET CANHELP TO MONITOR RESISTANCE
Legacy computersystems, qualityimprovement teams,and strategies foroptimizing antibioticuse have the potentialto stabilize resistanceand reduce costs by
encouragingheterogeneousprescribing patternsand use of local
susceptibility patternsto inform em iric
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World Antibiotic ResistanceNetwork
WHO has alsostarted another
program, WARN (theWorld AntibioticResistance Network),to help gather and
analyse the datagenerated by thepeople who use
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Are We Using It How much we use them ?
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Automated and semi automated systems
have been available for some years but
without full realization of their potential forrapid diagnosis. They fall into two maingroups: identification and susceptibilitytesting instruments and blood culture
systems. Whereas some identification andsusceptibility testing instruments take as longas traditional methods, others provide resultswithin a single working day.
Up gradation to Automation inCritical samples
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Blood culture systems have had considerable impact
on the ability to detect bacteremia. Growth isdetected through generation of a radiometric signalor a fluorescent or colorimetric indicator. Most truepositive results are detected within 24 to 36 hours.Identification and susceptibility results may beobtained in many blood culture isolates within the
same time when a blood culture system is combinedwith an automated identification or susceptibilitytesting instrument
Automation in Blood Culturingreduces mortality and Morbidity
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Blood culture systems have been adapted for the
automated or semi automated culture of
Mycobacterium tuberculosis and other mycobacteria.These commercial systems reduce the traditionaldependence on bio chemical reactions to identifyorganisms; avoid the and mycobacteria amongothers. Nucleic acid amplification systems are
available for the direct detection in clinicalspecimens of hepatitis C virus, HIV,M tuberculosis, C trachomatis, andN gonorrhea since morethan a decade.
Several Life threating conditionscan the treated Promptly
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Molecular techniques
Molecular biologicaltechniques have increasedthe speed and sensitivity of
detection methods, as wellas allowing laboratories toidentify organisms that donot grow or grow slowly inculture. These techniquesalso allow microbiologists toidentify genes that result inresistance to antibiotics andto fingerprint individualisolates for epidemiologicaltracking.
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New technologies enable to
New technologies
enable microbiology
results to beavailable in minutesor hours rather thandays.
Early diagnosisbetter prognosis andlesser costs intreatments
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Molecular biological methods
Nucleic acid probehybridization, thepolymerase chainreaction, the ligase chain
reaction, transcriptionmediated amplification,other evolvingamplification methods,and nucleic acidsequencing form the basis
of detecting andcharacterizing an everincreasing range ofviruses, bacteria, fungi,and protozoa
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Immunoassays have benefits
Immunoassays havebenefits of technical
simplicity, rapidity,specificity, and costeffectiveness butoften have poorsensitivity and lownegative predictivevalue
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Molecular Methods helps in
New trends in Recognition of newly
emerging infectiousdiseases and control ofantibiotic resistance in
Streptococcuspneumoniae,Haemophilus influenzaMoraxella catarrhalis,Staphylococcus aureus,
and Common Gramnegative bacilli will relyheavily on these newtechnologies.
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Limitations of Molecular Methods
The introduction ofmolecular diagnosticmethods in themicrobiologic diagnostic
laboratory is subject to anumber of practical andfinancial constraintsrequiring the elaboration ofa sound strategy. Validation
of the tests may require theuse of an expanded goldstandard or the applicationof novel statistical methodssuch as latent class analysis.
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The procedures should be constantly evaluated for false
positive an false negative results. The introduction ofmolecular methods will not only depend on their
performance for each individual microorganism, but also onthe clinical relevance of the diagnostic question asked,the prevalence of the clinical problem and whether the newmethods are added to the procedures in use or will replace
them. Therefore no general rules can be proposed,strategies have to be elaborated for each infectious agent orclinical syndrome
Limitations of Molecular Methods ?
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Microbiologists must plan
and Execute for changeWith increase in
availability of costeffective commercial
systems, laboratorieswill be able to capitalizeon the extremespecificity, high
sensitivity, and rapidityof these molecularapproaches.
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Better Diagnosis in Emerging
and Reemerging InfectionAn ever increasing
range of viruses,
bacteria fungi, andprotozoa can bedetected andcharacterized bymolecular biologicalmethods
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Studies prove that misuse of antibiotics may causepatients to become colonized or infected with
antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and highly-resistant Gram-negative bacilli.13-14
Misuse of antibiotics is also associated with anincreased incidence of Clostridium difficileinfections.15-17
Misuse of Antibiotics Drives
Antibiotic Resistance
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Spread of Antibiotic Resistance
Indiscrimate use ofAntibiotics in Animals andMedical practice
R plasmids spread amongco-inhabiting Bacterialflora in Animals ( in gut )
R plasmids may be mainlyevolved in Animals spreadto Human commensal, -Escherichia coli followedby spread to moreimportant humanpathogens Eg Shigella spp.
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Misuse of antibiotics can include any of the following
When antibiotics are prescribed unnecessarily;When antibiotic administration is delayed in critically ill
patients;When broad-spectrum antibiotics are used too generously, or
when narrow-spectrum antibiotics are used incorrectly;When the dose of antibiotics is lower or higher than
appropriate for the specific patient;When the duration of antibiotic treatment is too short or toolong;
When antibiotic treatment is not streamlined according tomicrobiological culture data results.
What is Misuse of
Antibiotics?
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Aim of Antibiotic
PolicyReduce the Antimicrobial resistanceInitiate best efforts in the hospital area as many
resistance Bacteria are generated in Hospitalareas and in particular critical care areas.Initiate good hygienic practices so these bacteria
do not spread to othersPractice best efforts, these resistance strains do
not spill into critically ill patients in the HospitalTo prevent spill into Society, as they present as
community associated infections..
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Objectives of Antibiotic Policy.
Antibiotics should not be used casuallyPolicy emphasizes, avoiding the use of
powerful Antibiotics in the Initial treatments.We should create awareness that we are
sparing the powerful Broad spectrum Drugsfor later treatment
Patient saves MoneyDoctors save Lives.
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Policy Deals on Broad
BasisClinicians /
Microbiologists /Pharmacists and
Nurses do take part. Policies are framed on
demands of the Clinicalareas, depending onrecent Infection
surveillance datacontributed fromMicrobiologyDepartments.
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Education On Antibiotic policy
Acton plan for Education to all concernedclinical staff on Antibiotic prescriptions.
Evaluate the feed back of success andfailures of the policy.Create Infection surveillance DataDeveloping facilities in Microbiology
departments for auditing data and
guidanceRestrictions in prescribing and Antibioticavailability.
A continuous education to Junior Doctors
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Staff Education on AntibioticPolicy
Staff education is most Important principle insuccess
Draw your own plans according to nature ofpatients, your past experiences
Induction training for new staffContinuing Medical Education to both Junior
and Senior DoctorsInclude nursing staff, pharmacists for the
success of the Programme
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Make your conclusions andcontribute to Antibiotic Policy
It is true to say that there is no absolute proofof causative association between antibiotic
use and resistance, But many authoritiesbelieve the association to be virtually certain.It is pragmatic and essential approach to
control of antibiotic resistance with controlof antibiotic use.
Make every one a partner in prevention ofAntibiotic resistance, and success will follow.
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Implementing better training anddevelopment opportunities for all staff andimproved recruitment and improve qualitystandards to produce Centres of Excellencefor Microbiology, with an increased pool ofconsultant expertise across sites
More efficient utilisation of facilities andequipment
Reasons for Forming a NetworkTo improve quality, efficiency and effectiveness
of the service leading to better patient care.
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Modernising Strategy
Managed Microbiology networks providing a wider strategiccontext for planning Microbiology services.Modernisation strategies to support service development.
Integrating Microbiology into wider service developments
Redesigning systems
Making effective use of IT and new technologies Medical
Informatics
Improving information management
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Modernisation Principles for
MicrobiologyPatient-centred
Appropriate
Develops staff
Integrated
Effective
Efficient
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Our changing Role Microbiologists can and
should play an importantrole in assuring thequality of results that are
generated by clinicalmicrobiologylaboratories. Their mostimportant role is to helpcorrelate clinical,laboratory, and
radiographic data, todetermine the clinicalrelevance, if any, ofmicrobiology test results
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Use of automation to improve and
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Use of automation to improve anddevelop services
Opportunity to develop new HR Strategy Reduced staff where employment difficult
Better use of qualified staff
Multidisciplinary use of staff
Improved Terms and Conditions
Develop services Point of Care Testing Molecular Biology
Diagnostic technicians
Greater efficiency Shift systems
Extended role for non-professional staff Better access times
More efficient and effective service Laboratory Ward
Community
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NDM 1 superbugs found in
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NDM-1 superbugs found inseepage, tap water
Gram-negative bacterialstrains with NDM-1 (NewDelhi Metallo-beta-lactamase-1) gene, alsocalled the superbug, havenow been detected indrinking water andseepage water samplescollected from severalsites in New Delhi.Seepage samples werecollected from waterpools found in streets orrivulets.
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Our Role Has changed withNDM-1 ?
Our role relates to thetimely reporting ofaccurate test results,which depends on thepractice of rigorous QC.There is no compellingreason to deviate fromthis practice, particularlybecause any test resultsthat would be generatedare likely to be clinicallyirrelevant, misleading, oreven dangerous topatients.
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Core Functions of Microbiology
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Core Functions of MicrobiologyLaboratories
1. Communicable disease surveillance, preventionand control2. Outbreak and emergency response to
communicable diseases3. Environmental health and food safety
4. Reference testing, specialized screening anddiagnostic testing5. Biosafety, containment, and biohazard response6. Integrated communicable disease data
management
7. Public health policy development and evaluation8. Laboratory Quality Assurance9. Training and education of health care workers10. Public health related research and development
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Systematic data collection &
interpretation of clinical and lab
informationMultidisciplinary team approach
Labs in community, hospitals, public
health all report to local public healthPublic health analyses and responds
Surveillance & OutbreakResponse Core Function
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S ill & O tb k
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Surveillance & OutbreakResponse Core Function
Why?
Ongoing watchfulness
Microbes impact quickly and widely
Microbes know no borders, changequickly
New patterns, novel pathogens, new tests
Alert for early diagnosis, interventionand prevention
NDM -1 should be approached withmultidisciplinary approach
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R h & T i i
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Research & TrainingCore Function
Faculty and staff carry out publichealth research and training
New knowledge about communicable
diseases (CDs) When novel pathogens appear, critical
skills (capacity)
Need to keep abreast of rapidlyadvancing technologies Many educational/training activities
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Best way to keep the matters
in OrderEvery Hospital should have a policy which is
practicable to their circumstances.
Rigid guidelines without coordination willlead to greater failures
The only way to keep Antimicrobial agentsuseful is to use them appropriately and
Judiciously(Burke A.Cunha, MD,MACP Antimicrobial Therapy. Medical
Clinics of North America NOV 2006)
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India is a country of 1.21 Billion population with complex
problems and unequal Medical Care. However we have aresponsibility to bring the concerns of Antibiotic misuse
both to the Professionals and Common man. Let us strengthen the Diagnostic Microbiology
Laboratories A good direction from Professionals on Antibiotic policy.
Net working and faster Education to all Health care workers. Better working conditions for Laboratory personal, frequent
training on quality of services Above all Technicians need better standard of Living to
improve the Laboratory services.
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How to Overcome NDM-1
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CDC & HHS Select Agents List
http://www.cdc.gov/od/sap/docs/salist.pdf
ABSA Risk Group Classification http://www.absa.org/resriskgroup.html
References
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http://www.cdc.gov/od/sap/docs/salist.pdfhttp://www.absa.org/resriskgroup.htmlhttp://www.absa.org/resriskgroup.htmlhttp://www.cdc.gov/od/sap/docs/salist.pdf8/7/2019 NDM - 1 Role of Diagnostic Microbiology
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Created by Dr.T.V.Rao MDon emerging concerns onNDM-1 Email