INTRODUCTION

I never thought I would land up in the jungle of laboratories. We do many tests to diagnose disease. Previously people used to see signs and symptoms. Doctors refer pathology report. Now a days group and manual methods are replaced by fully automated systems. The still remember in 1980s people used to go to the doctor. Used to believe that Dr. Dr used to be experienced enough to diagnose the probable cause. But still the confirmatory diagnosis was a challenge. Times change. The expensive non-affordable tests are now affordable because of technological advancement. The technological evolution leading all of the deceased to come to the conclusion of the cause and treatment. Become easy now to understand the prognosis. Evolution of quality of life initiated the confusion in diagnosis of the disease is as well. The evolution of microorganisms causing disease contributed to challenge the conventional signs and symptoms of particular diseases. We may not see the evolution but we are seeing the effect is of your leash, could as well as bad. The dynamic nature of the test result in laboratories leads the evolution of accreditation authorities. N ABL, CAP, US FDA, and many more... The status of laboratories especially the diagnostic laboratories is not very satisfactory in developing countries like India. At this point the national regulations have not made it compulsory for each lab to show the compliance for good laboratory practices. The poor awareness about the laboratory tests and negative business strategies like complement and commission to the doctors who are referring patients for testing to private labs are the basic challenges. Hospital attached side laboratories are run by the un-authorized personnel. In such hospitals, actually the doctors are conducting unnecessary tests to earn extra money. The education of laboratories technologist is demonstrable challenge. The under recognition of pathologists who work in the lab as a black box. How often we will hear the phrase, we are waiting for the results? What you are really waiting for his pathologists to make the diagnosis. Yet, whenever a public figure undergoes a biopsy or has a lab test, there is never any mention of the pathologists work behind the scenes.

Instead, there is often an incorrect conclusion that the surgeon or internist makes the diagnosis. While the suggestions may strongly suspect the diagnosis based upon their experience and expertise, the definitive and final diagnosis always rests with a pathologist. The laboratory is often the largest and most complex department of any hospital. This is where your blood samples, cultures, Pap smears, and biopsies are sent it is also were the phlebotomist is, the people who draw your blood samples, what many pathologists also were in outpatient, freestanding laboratories. These laboratory services physicians who do not work in the hospital. Patients in the country are increasingly becoming captive of an unholy nexus of doctors and diagnostic centers driven by an ethical greed. It has become a common knowledge in the society that Dr Stein to describe unnecessary medical tests for the patient is in exchange for commissions from diagnostic centers. Usually, a renowned diagnostic centers offer low commission. But less popular centers pay more, as they need promotion and doctors attention. The situation is so bad that many patients are scared of going to doctors fearing astronomical expands for unnecessary diagnostic tests. The national regulations are certainly lagging behind with the technological advances and healthcare revolution. Laboratory is an organized system which can be compared with any of the organized function. I have used the word organized with an intention. A not established process or function cannot be defined as organized. Going to talk strictly on the medical laboratories which are functioning in India.

Origin of laboratories:
Although rudimentary examinations of human body fluids date back to the time of the ancient Greek physician Hippocrates around 300 BC [2], it was not until 1896 that the first clinical laboratory was opened, a twelve-foot-by-twelve-foot room equipped at a cost of $50 at Johns Hopkins Hospital [3]. At that time, most laboratories consisted of little more than a corner in physicians' homes, offices, or hospital wards, with physicians performing the procedures themselves. The diagnostic and therapeutic value of laboratory testing was not yet appreciated, and many physicians viewed clinical laboratories simply as an expensive luxury that consumed both valuable space and time [4].

However, the discovery of the causative agents of devastating epidemics such as tuberculosis, diphtheria, and cholera in the 1880s and the subsequent development of tests for their detection in the late 1890s prompted a change in attitude, and by the turn of the century, the laboratory occupied a position of much greater importance. Pathologists began to train assistants, primarily young women, to perform some of the simpler laboratory procedures, freeing the pathologists to pursue advanced aspects of their specialty. In 1922, the American Society of Clinical Pathologists (ASCP) was formed to support the emerging clinical specialty of pathology. In 1926, the American College of Surgeons' accreditation standards decreed that all hospitals have a clinical laboratory under the direction of a physician, preferably a pathologist. This decree had the effect of ensuring that laboratories developed mainly in hospitals under the supervision of physicians [5]. World War I brought about a critical shortage of qualified laboratory assistants to staff the laboratories, prompting the creation of a wide variety of training programs to meet the growing need. In an effort to bring about a degree of standardization to the education of laboratory personnel, ASCP created the Board of Registry (BOR) in 1928 to certify individual laboratory technicians and later the Board of Schools (BOS) for the accreditation of educational programs. Individuals graduating from approved schools and passing the BOR's registry exam were thereafter referred to as medical technologists, identified by the acronym MT (ASCP). The parenthetical suffix was added to differentiate these individuals from MTs trained by non-ASCP approved commercial schools. Thus, although created primarily for the physician pathologist, ASCP played a pivotal role in the development of the clinical laboratory science field by establishing standards for both education and competency [6]. However, as the number of medical technologists swelled, they began to desire a greater degree of autonomy and control over the direction of their own profession than was available to them under the rule of ASCP. In 1933, a new organization was formed, the American Society of Clinical Laboratory Technicians (ASCLT), later renamed the American Society of Medical Technologists (ASMT). Although ASMT and ASCP worked closely together for many years, they disagreed over several critical issues, especially the accreditation of schools and certification of technologists, both of which

ASCP still controlled. In 1973, as a result of pressure from the U.S. Office of Education and the National Commission on Accrediting, ASCP agreed to disband the BOS and turn over its functions to an independently operated and governed board, the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) [7]. The issue of independent certification continued to be a source of discord until finally, in 1977, the ASMT withdrew its representatives from the BOR and established the autonomous certification agency, the National Certification Agency for Medical Laboratory Personnel (NCA) [8]. Having achieved independent oversight of both entry into the profession and certification of its member practitioners, clinical laboratory science was at last on its way to achieving the status of an independent profession. In today's era of rapidly evolving medical research and technology, one can hardly imagine a health care system without the contributions of clinical laboratory scientists. The laboratory analysis of blood and other body fluids plays an essential role in the diagnosis and treatment of disease, as well as in routine preventative medicine. In addition to performing an ever-expanding variety of laboratory analyses, clinical laboratory scientists are active in selecting test methodology and instrumentation, establishing and implementing quality assurance programs, and troubleshooting technological and instrument malfunctions. They hold upper-level management positions in clinical laboratories with responsibility for creating budgets, short- and long-term planning, and supervising laboratory personnel. In teaching institutions, clinical laboratory scientists (CLSs) at the master's and doctoral levels hold faculty positions in NAACLS-approved educational programs. The educational requirements for clinical laboratory science have evolved in tandem with the development and expansion of the scope of the field. In 1930 when the ASCP issued the first certificates of registration, the requirements consisted of graduation from high school, completion of one year of didactic work, and completion of six months of experience in a recognized laboratory [9]. As the body of knowledge increased in volume and complexity, the educational requirements gradually increased. By 1952, most approved schools required three years of college work, and, ten years later, the BOR formally increased the college prerequisite to three years [10]. During the 1960s, new categories of laboratory workers were created to help cope with the increased workload:

the certified laboratory assistant (CLA) with one year of training and the medical laboratory technician (MLT) with two years of training. Simultaneously, specialist categories in chemistry, microbiology, hematology, and blood banking were created. These were followed by the development of master's and doctoral programs to train CLSs for faculty positions at accredited schools. Numerous states currently require licensure of laboratory personnel, with others considering it, thus further ensuring the integrity of the profession. Owing to the origin of the field in hospital clinical laboratories, the majority of CLSs are still employed in this setting. In rural areas and small community hospitals, they are most likely to be generalists, but, in larger institutions with their wider scope of testing, many CLSs specialize in a specific departments. In recent years, nonhospital opportunities have proliferated in areas such as public health agencies, reference laboratories, forensics, blood and tissue banking, medical research, pharmaceutical companies, veterinary laboratories, industry, sales, marketing, consulting, and software development. However, just as the profession is nearing maturity, a combination of factors is threatening to produce a large-scale shortage of qualified laboratory personnel. In addition to the wide range of opportunities luring CLSs away from the clinical laboratory, additional factors contributing to the shortage include attrition due to persistently low salaries and lack of self-actualization, aging workforce, changing U.S. demographics, and increase in government regulation of clinical laboratories through the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) [11]. Ironically, the shortage is so critical that desperation has led some laboratories to consider hiring individuals without formal laboratory education and providing them with on the job training [12]. A review of the literature showed that few bibliometric studies have been conducted for the field of clinical laboratory science. In 1999, Siebers studied the error rate of references in articles published in the New Zealand Journal of Medical Laboratory Science [13]. In 1994, Watson and Perrin studied the coverage by the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and MEDLINE, both on CD-ROM, of the literature in four allied health areas: medical technology, medical records, radiologic technology, and respiratory therapy [14]. In this study, a group of faculty members from these four fields were asked to identify the top five or fewer journals that

they felt were core to their area. From the composite list, fifteen titles could be readily identified as being either from the field of medical technology or general medicine. Comparing these fifteen titles to the results of the present study, ten of them (67%) were included in Zone 1 of this study, four (27%) were in Zone 2, and only one (6%) was in Zone 3. Thus, Watson and Perrin's work provided early qualitative evidence of the core journals of the field, the results of which were expanded upon and quantified by the present study. The Watson and Perrin study also demonstrated the need to search both databases, as they found only a 30% overlap in the titles from the journal survey and a 14% overlap in citation retrieval.