NDM - 1 Role of Microbiology Laboratories
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Transcript of NDM - 1 Role of Microbiology Laboratories
Dr.T.V.Rao MD 1
Dr.T.V.Rao MD
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 2
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 3
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 pneumoniae strain 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 4
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 5
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 6
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 7
Toleman’s Study a Concern to India
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 8
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 9
Facts Reported on the Present Study
Facts on NDM-1 are Concern to
the National Health
Speech is silver
Silence is Gold
Ignoring the facts is Dangerous
Dr.T.V.Rao MD 10
Why Microbiologists are Important in the Changing Scenario
Adequate clinical management of infectious diseases relies primarily on the accurate identification of the causal micro-organism and the production of reliable information on its antimicrobial susceptibility
Dr.T.V.Rao MD 11
Now Clinicians Need Faster Diagnostic Information
Traditional diagnostic
methods in microbiology have lim-ited 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 12
Dr.T.V.Rao MD 13
Safety of the Laboratory Personal
A Top Priority
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 14
Let our Policy to start with Containment
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 15
Dr.T.V.Rao MD 16
Implementing Biosaftey at Medical Establishments in India
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.
Continues to be Most Neglected part of Diagnostic Microbiology
Can be Improved
Dr.T.V.Rao MD 17
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
Collecting the correct specimen most neglected part of Diagnostic Microbiology
Dr.T.V.Rao MD 18
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 sterile container
Dr.T.V.Rao MD 19
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
Dr.T.V.Rao MD 20
Labelling Specimens &
Infection 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 21
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 22
The major control on use , misuse of Antibiotics can be controlled with Good
Practices
Dr.T.V.Rao MD 23
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.
ANTIMICROBIAL SUSCEPTIBILITY TESTING
Dr.T.V.Rao MD 24
Quality Control on Antimicrobial testing is crucial
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 25
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
Adherence to CLSI Guidelines ..
Dr.T.V.Rao MD 26
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
Why All Diagnostic Laboratories should adhere to
Dr.T.V.Rao MD 27
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 28
Follow current practices as per
CLSI 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 29
Dr.T.V.Rao MD 30
Implementation of WHONET CAN HELP TO MONITOR RESISTANCE
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.
World Antibiotic Resistance Network
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 31
Are We Using It – How much we use them ?
Dr.T.V.Rao MD 32
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.
Up gradation to Automation in Critical samples
Dr.T.V.Rao MD 33
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
Automation in Blood Culturing reduces mortality and Morbidity
Dr.T.V.Rao MD 34
Blood culture systems have been adapted for the
automated or semi automated culture of Mycobacterium tuberculosis 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.
Several Life threating conditions can the treated Promptly
Dr.T.V.Rao MD 35
Molecular techniques
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 36
New technologies enable 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 37
Molecular biological methods
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 38
Immunoassays have benefits
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 39
Molecular Methods helps in
New trends in… Recognition of newly
emerging infectious diseases and control of antibiotic resistance in Streptococcus pneumoniae, Haemophilus influenza Moraxella catarrhalis, Staphylococcus aureus, and Common Gram negative bacilli will rely heavily on these new technologies.
Dr.T.V.Rao MD 40
Limitations of Molecular Methods
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 41
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
Limitations of Molecular Methods ?
Dr.T.V.Rao MD 42
Microbiologists must plan and Execute for change
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 43
Better Diagnosis in Emerging and Reemerging Infection
An ever increasing range of viruses, bacteria fungi, and protozoa can be detected and characterized by molecular biological methods
Dr.T.V.Rao MD 44
Dr.T.V.Rao MD 45
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
Misuse of Antibiotics Drives Antibiotic Resistance
Dr.T.V.Rao MD 46
Spread of Antibiotic Resistance
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 47
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.
What is Misuse of Antibiotics?
Dr.T.V.Rao MD 48
Aim of Antibiotic Policy
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 49
Objectives of Antibiotic Policy.
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 50
Policy Deals on 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 51
Education On Antibiotic policy
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 52
Staff Education on Antibiotic Policy
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 53
Make your conclusions and contribute to Antibiotic Policy
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 54
Dr.T.V.Rao MD 55
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
Reasons for Forming a Network To improve quality, efficiency and effectiveness
of the service leading to better patient care.
Dr.T.V.Rao MD 56
Modernising Strategy
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 57
Modernisation Principles for Microbiology
Patient-centred
Appropriate
Develops staff
Integrated
Effective
Efficient
Dr.T.V.Rao MD 58
Our changing Role 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 59
Use of automation to improve and develop 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 Dr.T.V.Rao MD 60
NDM-1 superbugs found in seepage, tap water
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 61
Our Role Has changed with NDM-1 ?
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 62
Core Functions of Microbiology Laboratories
1. Communicable disease surveillance, prevention and control
2. Outbreak and emergency response to communicable diseases
3. Environmental health and food safety 4. Reference testing, specialized screening and
diagnostic testing 5. Biosafety, containment, and biohazard response 6. Integrated communicable disease data
management 7. Public health policy development and evaluation 8. Laboratory Quality Assurance 9. Training and education of health care workers 10. Public health related research and development
Dr.T.V.Rao MD 63
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
Surveillance & Outbreak Response Core Function
Dr.T.V.Rao MD 64
Surveillance & Outbreak Response Core Function
Why?
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 65
Research & Training Core 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 66
Best way to keep the matters in Order
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 67
India is a country of 1.21 Billion population with complex problems and unequal 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 68
How to Overcome NDM-1
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
Dr.T.V.Rao MD 69