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NDM-1GROWING CONCERNSNeed for Modernization of Diagnostic Microbiology Laboratories

Dr.T.V.Rao MD

Dr.T.V.Rao MD

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The Lancet Opens the Pandora box

  • Gram-negative Enterobacteriaceae with resistance to carbapenems conferred by New Delhi metallo-β-lactamase 1 (NDM-1) are potentially a major global health problem. We investigated the prevalence of NDM-1, in multidrug-resistant Enterobacteriaceae in India, Pakistan, and the UK.

Dr.T.V.Rao MD

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Travel makes patients venerable

  • The superbug called New Delhi metallo-beta-lactamase, or NDM-1, was identified in 50 people who traveled to India or Pakistan for surgery and then returned to the United Kingdom, British scientists reported in the journal Lancet Infectious Diseases

Dr.T.V.Rao MD

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Naming the strain as New Delhi creates controversy

  • The gene was named after New Delhi, the capital city of India, as it was first described by Yong et al. in 2009 in a Swedish national who fell ill with an antibiotic-resistant bacterial infection that he acquired in India . The infection was unsuccessfully treated in a New Delhi hospital and after the patient's repatriation to Sweden, a carbapenem-resistant Klebsiella pneumoniaestrain bearing the novel gene was identified. The presenting authors concluded that the new resistance mechanism "clearly arose in India, but there are few data arising from India to suggest how widespread it is."

Dr.T.V.Rao MD

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Bugs becomes Superbugs

  • Antibiotic resistance develops through gene action or plasmid exchange between bacteria of the same species. If a bacterium carries several resistance genes, it is called multiresistant or, informally, a superbug.

Dr.T.V.Rao MD

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CDC Reports

Three Enterobacteriaceae isolates carrying a newly described resistance mechanism, the New Delhi metallo-beta-lactamase (NDM-1) , were identified from three U.S. states at the CDC antimicrobial susceptibility laboratory. This is the first report of NDM-1 in the United States, and the first report of metallo-beta-lactamase carriage among Enterobacteriaceae in the United States

Dr.T.V.Rao MD

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Mark Toleman of Britain's Cardiff University School of Medicine, creates concerns ?

  • The inhabitants of New Delhi are continually being exposed to multidrug-resistant and NDM 1-positive bacteria," said Mark Toleman of Britain's Cardiff University School of Medicine, who published the findings in a study on Thursday.

Dr.T.V.Rao MD

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Toleman’s Study a Concern to India Medicine

  • Toleman’s study, carried out with Cardiff University’s Timothy Walsh and published in The Lancet Infectious Diseases journal, investigated how common NDM 1-producing bacteria are in community waste seepage — such as water pools or rivulets in streets — and tap water in urban New Delhi.

Dr.T.V.Rao MD

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Facts Reported on the Present Study Medicine

  • In September and October 2010, Walsh’s research team collected 50 samples from public drinking water taps in New Delhi and 171 samples from “seepage,” standing water that had pooled near public areas, both of which are used by residents for drinking, washing and/or other household functions. The scientists found bacterial strains with the NDM-1 mutation in two of the drinking water samples and in 51 of the seepage samples. For comparison, they collected 70 samples from Cardiff’s water supply and found no evidence of bacteria with NDM-1 mutations.

Dr.T.V.Rao MD

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Facts on MedicineNDM-1 are Concern to the National Health

  • Speech is silver

  • Silence is Gold

  • Ignoring the facts is Dangerous

NDM - 1

Dr.T.V.Rao MD

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Why Microbiologists are Important in the Changing Scenario Medicine

  • Adequate clinical management of infectious diseases relies primarily on the accurate identification of the causal micro­organism and the production of reliable information on its antimicrobial susceptibility

Dr.T.V.Rao MD

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Now Clinicians Need Faster Diagnostic Information Medicine

  • Tra­ditional diagnostic methods in microbiology have lim­ited the ability of laboratories to provide doctors with timely and clinically relevant information, but recent technology provides results in minutes or hours rather than days or weeks.

Dr.T.V.Rao MD

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Improving the Standards in MedicineDiagnostic Microbiology

Dr.T.V.Rao MD

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Safety of the Laboratory Personal A Top Priority Medicine

  • The protection of personnel and the immediate laboratory environment from exposure to infectious agents is provided by both good microbiological technique and the use of appropriate safety equipment. The use of vaccines may provide an increased level of personal protection.

Dr.T.V.Rao MD

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Let our Policy to start with MedicineContainment

  • The term "containment" is used in describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents.

Dr.T.V.Rao MD

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Implementing Biosaftey at Medical Establishments in India Medicine

  • It is time to educate on Biosafety issues. Document the Information regarding the Biosaftey equipment available in the Hospital, Colleges, if not, to do at the earliest, and concerns of the Health of the Laboratory personal should be made mandatory.

Dr.T.V.Rao MD

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Specimen collection Medicine

Continues to be Most Neglected part of Diagnostic Microbiology

Can be Improved

Dr.T.V.Rao MD

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Collecting the correct Medicinespecimen most neglected part of Diagnostic Microbiology

  • 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 is lost in unscientific methods, left casually to ill trained staff

Dr.T.V.Rao MD

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Getting the specimen to the laboratory Medicine

  • 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 sterile container

Dr.T.V.Rao MD

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Collecting the specimen correctly Medicine

  • 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

Dr.T.V.Rao MD

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Labelling Specimens & MedicineInfection Control

  • Please be considerate to lab staff!!

    • Label hazardous specimens

  • Don't send specimens to the lab without proper packing

    • Leaking or blood-stained specimens are not acceptable!!!

Dr.T.V.Rao MD

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Factors limiting usefulness of bacteriological investigations What is going Wrong

  • Wrong 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

Dr.T.V.Rao MD

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The major control on use , misuse of Antibiotics can be controlled with Good Practices

Dr.T.V.Rao MD

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  • The role of antimicrobial susceptibility tests to guide empirical therapy, to refine therapy once pathogens have been isolated and identified, and to detect new types of antimicrobial resistance is well established. Other roles of antimicrobial susceptibility testing for patient care, such as development of cumulative Antibiograms, creation of antimicrobial formularies, and detection of new antimicrobial resistance strains or trends, are also well established.

Dr.T.V.Rao MD

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Quality Control on Antimicrobial testing is crucial investigations

  • Generating accurate and reproducible antimicrobial susceptibility test data requires perhaps the most extensive QC program used in clinical laboratories today

Dr.T.V.Rao MD

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Adherence to CLSI Guidelines .. investigations

  • The CLSI publishes guidelines for the QC of antimicrobial susceptibility tests . These guidelines are extensive and require rigorous adherence to each step of testing for results to be accurate and reproducible. Specific guidelines have been developed not only for different categories of bacteria and fungi (e.g., members of the Enterobacteriaceae family) but also for individual species. Perhaps the most important guidelines published by CLSI are that antimicrobial agents should be tested against different microbial pathogens

Dr.T.V.Rao MD

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Why All Diagnostic Laboratories should adhere to investigations

  • The information used to develop these guidelines is based on clinical, pharmacologic, and microbiologic data. It is strongly recommended that clinical microbiology laboratories and providers both adhere to these guidelines; testing antimicrobial agent–pathogen combinations that are not recommended may generate antimicrobial susceptibility test results that either are misleading or cannot be interpreted.

  • In general, it is also strongly recommended that new antimicrobial agents should not be tested in clinical laboratories until there are sufficient data for CLSI guidelines to be developed and published

Dr.T.V.Rao MD

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Reporting newer pattern of Resistance needs reference Methods

  • Detection of new types or patterns of antimicrobial resistance may be fortuitous or the result of active surveillance. The former should not be used to guide patient care until the data are confirmed by a reference method; published reports of new types or patterns of resistance typically reflect extensive confirmatory testing.

Dr.T.V.Rao MD

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Follow current practices as per MethodsCLSI guidelines

  • Most microbiology laboratories use commercial systems for antimicrobial susceptibility testing, which may or may not yet have the capability of detecting newer forms of resistance, reliable means of detecting new types or patterns of antimicrobial resistance often lag behind published information.

Dr.T.V.Rao MD

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  • Legacy computer systems, quality improvement teams, and strategies for optimizing antibiotic use have the potential to stabilize resistance and reduce costs by encouraging heterogeneous prescribing patterns and use of local susceptibility patterns to inform empiric treatment.

Dr.T.V.Rao MD

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World Antibiotic Resistance Network Methods

  • WHO has also started another program, WARN (the World Antibiotic Resistance Network), to help gather and analyse the data generated by the people who use WHONET.

Dr.T.V.Rao MD

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Recent MethodsadvancesDiagnostic Microbiology

Are We Using It – How much we use them ?

Dr.T.V.Rao MD

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Up gradation to Automation in Critical samples Methods

  • Automated and semi automated systems have been available for some years but without full realization of their potential for rapid diagnosis. They fall into two main groups: identification and susceptibility testing instruments and blood culture systems. Whereas some identification and susceptibility testing instruments take as long as traditional methods, others provide results within a single working day.

Dr.T.V.Rao MD

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Automation in Blood Culturing reduces mortality and Morbidity

  • Blood culture systems have had considerable impact on the ability to detect bacteremia. Growth is detected through generation of a radiometric signal or a fluorescent or colorimetric indicator. Most true posi­tive results are detected within 24 to 36 hours. Identifi­cation and susceptibility results may be obtained in many blood culture isolates within the same time when a blood culture system is combined with an automated identification or susceptibility testing instrument

Dr.T.V.Rao MD

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Several Life threating conditions can the treated Promptly Morbidity

  • Blood culture systems have been adapted for the automated or semi automated culture of Mycobacteriumtuberculosis and other mycobacteria. These commercial systems reduce the traditional dependence on bio­ chemical reactions to identify organisms; avoid the and mycobacteria among others. Nucleic acid amplifica­tion systems are available for the direct detection in clinical specimens of hepatitis C virus, HIV, M tuberculo­ sis, C trachomatis, and N gonorrhea since more than a decade.

Dr.T.V.Rao MD

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Molecular techniques Morbidity

  • Molecular biological techniques have increased the speed and sensitivity of detection methods, as well as allowing laboratories to identify organisms that do not grow or grow slowly in culture. These techniques also allow microbiologists to identify genes that result in resistance to antibiotics and to “fingerprint” individual isolates for epidemiological tracking.

Dr.T.V.Rao MD

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New technologies Morbidityenable to …

  • New technologies enable microbiology results to be available in minutes or hours rather than days.

  • Early diagnosis better prognosis and lesser costs in treatments

Dr.T.V.Rao MD

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Molecular biological methods Morbidity

  • Nucleic acid probe hybridization, the polymerase chain reaction, the ligase chain reaction, transcription medi­ated amplification, other evolving amplification meth­ods, and nucleic acid sequencing form the basis of detecting and characterizing an ever increasing range of viruses, bacteria, fungi, and protozoa

Dr.T.V.Rao MD

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Immunoassays have benefits Morbidity

  • Immunoassays have benefits of technical simplicity, rapidity, specificity, and cost effectiveness but often have poor sensitivity and low negative predictive value

Dr.T.V.Rao MD

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Molecular Methods helps in New trends in Morbidity…

  • Recognition of newly emerging infectious diseases and control of antibiotic resistance in Streptococcus pneumoniae, Haemophilus influenzaMorax­ella catarrhalis, Staphylococcus aureus, and Common Gram negative bacilli will rely heavily on these new technologies.

Dr.T.V.Rao MD

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Limitations of Molecular Methods Morbidity

  • The introduction of molecular diagnostic methods in the microbiologic diagnostic laboratory is subject to a number of practical and financial constraints requiring the elaboration of a sound strategy. Validation of the tests may require the use of an expanded gold standard or the application of novel statistical methods such as latent class analysis.

Dr.T.V.Rao MD

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Limitations of Molecular MorbidityMethods ?

  • The procedures should be constantly evaluated for false positive an false negative results. The introduction of molecular methods will not only depend on their performance for each individual microorganism, but also on the clinical relevance of the diagnostic question asked, the prevalence of the clinical problem and whether the new methods 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 or clinical syndrome

Dr.T.V.Rao MD

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Microbiologists must plan and Execute for change Morbidity

  • With increase in availability of cost effective commercial systems, laboratories will be able to capitalize on the extreme specificity, high sensitivity, and rapidity of these molecular approaches.

Dr.T.V.Rao MD

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Better Diagnosis in Emerging and Reemerging Infection Morbidity

  • An ever increasing range of viruses, bacteria fungi, and protozoa can be detected and characterized by molecular biological methods

Dr.T.V.Rao MD

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Dr.T.V.Rao MD

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Misuse of MorbidityAntibiotics Drives Antibiotic Resistance

  • Studies prove that misuse of antibiotics may cause patients 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 an increased incidence of Clostridium difficile infections.15-17

Dr.T.V.Rao MD

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Spread of Antibiotic Resistance Morbidity

  • Indiscrimate use of Antibiotics in Animals and Medical practice

  • R plasmids spread among co-inhabiting Bacterial flora in Animals ( in gut )

  • R plasmids may be mainly evolved in Animals spread to Human commensal, - Escherichia coli followed by spread to more important human pathogens Eg Shigella spp.

Dr.T.V.Rao MD

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What is MorbidityMisuse of Antibiotics?

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 too long;

  • When antibiotic treatment is not streamlined according to microbiological culture data results.

Dr.T.V.Rao MD

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Aim of Antibiotic Policy Morbidity

  • Reduce the Antimicrobial resistance

  • Initiate best efforts in the hospital area as many resistance Bacteria are generated in Hospital areas and in particular critical care areas.

  • Initiate good hygienic practices so these bacteria do not spread to others

  • Practice best efforts, these resistance strains do not spill into critically ill patients in the Hospital

  • To prevent spill into Society, as they present as community associated infections..

Dr.T.V.Rao MD

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Objectives of Antibiotic Policy Morbidity.

  • Antibiotics should not be used casually

  • Policy emphasizes, avoiding the use of powerful Antibiotics in the Initial treatments.

  • We should create awareness that we are sparing the powerful Broad spectrum Drugs for later treatment

    Patient saves Money

    Doctors save Lives.

Dr.T.V.Rao MD

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Policy Deals Morbidityon Broad Basis

  • Clinicians / Microbiologists / Pharmacists and Nurses do take part.

  • Policies are framed on demands of the Clinical areas, depending on recent Infection surveillance data contributed from Microbiology Departments.

Dr.T.V.Rao MD

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Education On Antibiotic policy Morbidity

  • Acton plan for Education to all concerned clinical staff on Antibiotic prescriptions.

  • Evaluate the feed back of success and failures of the policy.

  • Create Infection surveillance Data

  • Developing facilities in Microbiology departments for auditing data and guidance

  • Restrictions in prescribing and Antibiotic availability.

  • A continuous education to Junior Doctors

Dr.T.V.Rao MD

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Staff Education on Antibiotic MorbidityPolicy

  • Staff education is most Important principle in success

  • Draw your own plans according to nature of patients, your past experiences

  • Induction training for new staff

  • Continuing Medical Education to both Junior and Senior Doctors

  • Include nursing staff, pharmacists for the success of the Programme

Dr.T.V.Rao MD

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Make your conclusions and contribute to Antibiotic Policy Morbidity

  • It is true to say that there is no absolute proof of causative association between antibiotic use and resistance, But many authorities believe the association to be virtually certain.

  • It is pragmatic and essential approach to control of antibiotic resistance with control of antibiotic use.

  • Make every one a partner in prevention of Antibiotic resistance, and success will follow.

Dr.T.V.Rao MD

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Reasons for Forming a MorbidityNetworkTo improve quality, efficiency and effectiveness of the service leading to better patient care.

  • Implementing better training and development opportunities for all staff and improved recruitment and improve quality standards to produce Centres of Excellence for Microbiology, with an increased pool of consultant expertise across sites

  • More efficient utilisation of facilities and equipment

Dr.T.V.Rao MD

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Modernising Strategy Morbidity

Managed Microbiology networks providing a wider strategic context 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

Dr.T.V.Rao MD

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Modernisation Principles for Microbiology Morbidity

  • Patient-centred

  • Appropriate

  • Develops staff

  • Integrated

  • Effective

  • Efficient

Dr.T.V.Rao MD

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Our changing Role Morbidity

  • Microbiologists can and should play an important role in assuring the quality of results that are generated by clinical microbiology laboratories. Their most important role is to help correlate clinical, laboratory, and radiographic data, to determine the clinical relevance, if any, of microbiology test results

Dr.T.V.Rao MD

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Use of automation to improve and develop services Morbidity

  • 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

Dr.T.V.Rao MD

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NDM-1 superbugs found in seepage, tap water Morbidity

  • Gram-negative bacterial strains with NDM-1 (New Delhi Metallo-beta-lactamase-1) gene, also called the superbug, have now been detected in drinking water and seepage water samples collected from several sites in New Delhi. Seepage samples were collected from water pools found in streets or rivulets.

Dr.T.V.Rao MD

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Our Role Has changed with NDM-1 ? Morbidity

  • Our role relates to the timely reporting of accurate test results, which depends on the practice of rigorous QC. There is no compelling reason to deviate from this practice, particularly because any test results that would be generated are likely to be clinically irrelevant, misleading, or even dangerous to patients.

Dr.T.V.Rao MD

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Core Functions Morbidityof Microbiology Laboratories

  • Communicable disease surveillance, prevention and control

  • Outbreak and emergency response to communicable diseases

  • Environmental health and food safety

  • Reference testing, specialized screening and diagnostic testing

  • Biosafety, containment, and biohazard response

  • Integrated communicable disease data management

  • Public health policy development and evaluation

  • Laboratory Quality Assurance

  • Training and education of health care workers

  • Public health related research and development

Dr.T.V.Rao MD

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Surveillance & Outbreak Response Core Function Morbidity

  • Systematic data collection & interpretation of clinical and lab information

  • Multidisciplinary team approach

  • Labs in community, hospitals, public health all report to local public health

  • Public health analyses and responds

Dr.T.V.Rao MD

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Surveillance & Outbreak Response Core Function Morbidity


  • Ongoing watchfulness

  • Microbes impact quickly and widely

  • Microbes know no borders, change quickly

  • New patterns, novel pathogens, new tests

  • Alert for early diagnosis, intervention and prevention

  • NDM -1 should be approached with multidisciplinary approach

Dr.T.V.Rao MD

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Research & Training MorbidityCore Function

  • Faculty and staff carry out public health research and training

  • New knowledge about communicable diseases (CDs)

  • When novel pathogens appear, critical skills (capacity)

  • Need to keep abreast of rapidly advancing technologies

  • Many educational/training activities

Dr.T.V.Rao MD

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Best way to keep the matters in Order Morbidity

Every Hospital should have a policy which is practicable to their circumstances.

Rigid guidelines without coordination will lead to greater failures

The only way to keep Antimicrobial agents useful is to use them appropriately and Judiciously

(Burke A.Cunha, MD,MACP Antimicrobial Therapy. Medical Clinics of North America NOV 2006)

Dr.T.V.Rao MD

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How to Overcome NDM-1 Morbidity

  • India is a country of 1.21 Billion population with complex problems andunequal Medical Care. However we have a responsibility 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.

Dr.T.V.Rao MD

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References Morbidity

  • CDC & HHS Select Agents List

  • http://www.cdc.gov/od/sap/docs/salist.pdf

  • ABSA Risk Group Classification

  • http://www.absa.org/resriskgroup.html

Dr.T.V.Rao MD