Standardization and quality control in medical laboratories are essential to ensure accurate test results and credible data. Laboratories need to implement procedures like documentation, standard operating procedures, quality control samples, and external quality assessment to reliably monitor testing and calibration. Achieving quality requires tools like procedure manuals, maintenance schedules, calibrations, training, and quality control. The current state of many private laboratories in India is problematic, as testing and reporting of bacteriological cultures is often done without proper qualifications, leading to inaccurate reporting of antibiotic sensitivity and a risk of increasing antibiotic resistance. Regulations and accountability are needed to improve standards in medical laboratories.

1. WHY THE LABORATORIES NEED
QUALITY CONTROL AND STANDARDIZATION
Dr.T.V.Rao MD
Quality control in the medical laboratory is a statistical process used to monitor and evaluate the
analytical process that produces patient results. Well-executed standardization programs greatly
improve the quality of laboratory measurements that are used to detect signs of illnesses and to
guide interventions to prevent or treat illnesses. Standardization also ensures the production of
credible and comparable data across laboratories—a boon to epidemiologists and researchers who
may need to pool data from multiple sources. Today Medical profession is Money making machine
for many by so many vagaries in the System, Government of India has started Many Medical
colleges, to stop the quackery, and to replace the Medical Profession with qualified Doctors,
However the Laboratory system never touched by the Medical council of India or Ministry of health,
there are many dangers await to the innocent people by the inefficient and commission oriented
Laboratories, Today many qualified Doctors are least interested in doing a proper clinical evaluation,
and have become believers of the Laboratories, and going to harm many innocent people when the
conflicts of interests are very high, as when the Doctors send for MRI, and CT scans many can get
faster easier money than the consultation. The condition of private laboratories are really pathetic
as far concerned with Microbiology. A person without any proper qualification talk many things,
without doing a proper culture examination, and all irrelevant Antibiotics are tested on every isolate,
and reported to be sensitive, and really quackery enter when the Doctors believe the Medical
representatives and have least time to read the fundamentals of Antibiotics, I am happy one of my
senior colleague talked in one the conference In India it is impossible to implement the Antibiotic
policy, Antibiotic stewardship as the matters have become out of control, in this process India and
like some developing Nations will become a paradise for SUPERBUGS. Never forget we are all
potential future patients and SUPERBUGS do not spare us, and we will kill many of our patients, if
there is no proper beginning with implementing minimal standards in the system, which depends on
reliable assessment of testing and calibration laboratories, inspection agencies and fabricator
inspection programs. Accurate test, calibration and inspection results are vital for the protection of
public health and safety and to facilitate trade. Some where we have to improve with Proficiency
testing and inter laboratory comparisons are two closely related methods that a laboratory may use
to demonstrate technical competence. PT/ILC provides independent feedback concerning a
laboratory's actual performance, and can be used as a tool to monitor improvement efforts. In
future India has to progress from vagaries by the private laboratories without proper accountability
it is a life threat to innocent patients however we can make it, if the law makers to initiate guidelines
for accountability in the private laboratories, However The maintenance of a quality management
system is crucial to a laboratory for providing the correct test results every time. Important elements
of a quality management system include: we can begin with
Documentation
Standard Operating Procedures (SOP's)
Quality Control samples
External Quality Assessment Scheme

2. Quality control
Are procedures used in each assay to assure a test run is valid and results are reliable?
Kit Controls
Quality Control Samples
Never forget we need many efforts to improve our laboratory system Achieving quality in the
medical laboratory requires the use of many tools. These include procedure manuals, maintenance
schedules, calibrations, a quality assurance program, training and quality control. I wish to express
one thing with certainty, testing Bacteriological cultures and identification without qualified Medical
personal is a life threat to many, Nevertheless the Future Generation of Medical Microbiologists
should fight for their place in the system to make the matters creditable with integrity and
professionalism. If there are no minimal regulations in the system WILL BE A GENERATOR OF MANY
SUPERBUGS, Just think who is at Risk the patient, you, me and every one ? The grave life threat
awaits from many Bacteriology laboratories run without qualified people start reporting every
bacterial isolate with every available antibiotic and the physicians choosing these reports to treat is a
grave life threat. And spread of undesired Antibiotic resistance in the hospital environment and
create SUPERBUGS I pray we should not be victims in the system of laboratories which are loaded
with kickbacks and quackery and non-scientific approaches?
Dr.T.V.Rao MD Professor of Microbiology Freelance writer