Clinical Pathology (CP) or Laboratory Medicine (LM): What is there in the Name?

Response from Other Departments at AIIMS

The responses from other departments were strong and this was because of LM department’s financial and administrative independence, and also the utility. The immediate response from Hospital Administration was that the Faculties there are nothing but glorified technicians! The departments of Pathology, Biochemistry, and Microbiology kept their fingers crossed maintaining silence, with a policy of wait and watch. Medical disciplines such as Medicine and Paediatrics gradually developed trust in LM discipline. Surgical disciplines continued to love the Department of Pathology for their Anatomic Pathology diagnosis. Other diagnostic department such as Radiology started dreaming for a combined diagnostic centre at AIIMS in near future. Amidst such a varied environment and neighbours the Department, nine years following its inception, started a medical postgraduate MD course in 1997. In the same year, the faculties started taking their students under the PhD program as well. Structured research activities began.

From AIIMS to National Fruition

Many ups and downs punctuated the course of LM discipline at AIIMS. Five consecutive Directors following its inception were from surgical disciplines. The growth curve of the department maintained a plateau and often with many dips. However, the third of the five such Directors who was a cardiac surgeon and of national repute for the first heart transplantation in India, realized the relevance and growth potential of the discipline and put the proposal for a Diagnostic Centre in the 12th five-year plan of the Institute for Govt. of India. In this period, the residents suffered from uncertainties of their future and were worried about their careers. Being inducted from different disciplines, faculties had their feeling of stagnation and often suffocation with its behavioural consequences. The dawn of National fruition of the discipline was, however, ushered when a Director from the Medicine discipline took over as AIIMS chief, and a Paediatrician took over the charge of MCI (with another paediatrician as his chief assistant and in-charge of postgraduate section). Any cognizable programmed change requires the “critical mass” of the medical community for its acceptance by the Nation. During 2018-19, the present author organized support letters from 40 odd eminent Medical Academicians and Laboratory Professionals across the North, South, East and West of India, including Professors of Biochemistry, Pathology, Haematology, and Microbiology of reputed Medical College and Institutes, and submitted to MCI. The result was obvious. The discipline and the postgraduate training program got recommended for the Nation by the MCI.

Laboratory Medicine: Prevalent Definitions

Laboratory Medicine is a medical field that encompasses the selection, operation and interpretation of diagnostic testing that uses primarily the specimens from patients and contributes to clinical management [6]. The emphasis is more on the application and the service aspects rather than on the conceptual aspects of the pathological, biochemical and microbiological basis of the disease. Recently the definition of Laboratory Medicine has been revised as “a clinical science and discipline, devoted to the quantitative measurement, or qualitative assessment, of any substance which can be assayed in any type of biological fluid of any animal species, thus including humans, for either medical or research purposes. The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population” [7]. The definition uses Laboratory Medicine as the umbrella discipline under which all laboratory-related departments function.

The Initial Own Niche of Laboratory Medicine

The routine laboratory investigations in most of the hospitals and teaching institutions comprising of hematological, biochemical, microbiological, and body fluid tests constitute about 70-80% of all laboratory investigations. However, this is considered as no laboratory physician’s land, or every laboratory physician’s land, and is practically given over to laboratory technologists on the ground to look into. In the first step of formulation of LM, this area becomes the central core niche appended with the centralized common specimen collection centre [8]. The boundary makes the Tier-I of all medical laboratories in a teaching institute. To put it in a proper perspective in the total scheme of hospital laboratories in a tertiary care hospital and teaching medical institution, the Laboratory Medicine department belongs to Tier I, the departments of Pathology, Microbiology, and Biochemistry make Tier II, and the common centralized research facility laboratory with high-end costly equipment forms Tier III [9]. Once Tier I takes a definite shape, the next step to progress is to bring all claimant specialists as the faculty in Tier-I, and administratively declare the area as a department, independent of other specialty laboratories  like Anatomic Pathology, Biochemistry, and Microbiology. No medical department in a teaching hospital can survive without a residency program and a sustainable fruitful course. Therefore, in step three, starting a medical postgraduate course with a residency program leading to a medical postgraduate degree is the most desired and sensible deed.

The Gains and the Long Term Perspectives

Immediate gains from a department of LM are the one- window solution for patients, minimum turn-around time in the investigation, and combined integrated interpretative reporting of biochemical, hematological, and microbiological investigations. Subsequent gain with the postgraduate training program is the development of the expert resources of laboratory quality managers, and a pool of laboratory educators and trainers. Since reliable laboratory results are the hard evidence for the practice of evidence-based medicine, this area becomes the research and publication hub. Internal Medicine gets strengthened by the effective dynamics of Laboratory Medicine. In the long run, diagnostic service for the nation becomes cost-effective for both patients and the nation. This is in terms of the knowledge-economy, manpower-economy, infrastructure-economy, and health- economy. This new course can offer an additional option for postgraduate-aspirants in the country. The scheme opens job opportunities for faculties and new specialist experts. Because of cost-effectiveness, this enterprise is sustainable from the city to countryside hospitals and for running the Point-of-Care during pandemics and national disasters through an inflatable lab or the ‘lab on a wheel’.

Laboratory Medicine at AIIMS, Delhi

Any postgraduate course requires a Foundational Framework. Following several ups and downs, the Foundational Framework of LM has been laid down [10]. The expected skills to be learned during three-year residency program have been defined by the department [11] as well as by NMC [3]. The goal of the course is to produce the ‘Laboratory physicians of first contact’, with desirable postgraduate competency in knowledge skill and attitude; the first contact for both clinicians and patients. During clinical rounds, LM residents help clinical colleagues in test selection and test interpretation. They help patients in the pre-test and post-test counselling, and post-test referral. The operational training for the residents are on most of the tests included as WHO’s higher-priority Essential Diagnostic List, and the tests listed in the National Diagnostic Essential List of the Indian Council of Medical Research, which is based on the global and national needs respectively [12]. The one- fourth of the total curriculum of LM consists of Laboratory Management and Quality Assurance.

The training in Laboratory Medicine has been institutionalized at AIIMS, Delhi. At the beginning of every postgraduate semester, the  LM department runs an orientation program for the newly appointed residents of all clinical departments. The residents from some of the clinical departments (e.g., Paediatrics) are posted for a specified period in the laboratory medicine to strengthen their skill of how to utilize the laboratory for best clinical management. The residents from Pathology and Biochemistry departments also have their rotational posting in the Laboratory Medicine department. The combined seminars with the department of Pathology have been running since the time of inception of the LM department. In order to increase the awareness towards the current-day-laboratories and its functioning, the undergraduates at AIIMS are sensitized on ‘Pre-Analytical Variables Influencing the Laboratory Results’ and different ‘Organ Function Tests’ by the Laboratory Medicine faculties in terms of a large group and small group teaching.

Laboratory Medicine: The Global Aspect

In the United States of America, the specialty of Laboratory Medicine functions as a branch of Pathology (where Pathology is the generic name for all diagnostic laboratories). There is 3-year Anatomic Pathology (AP), 3-year Clinical Pathology (AP) and a 4-year AP-CP combined training course. In many European countries, Laboratory Medicine is considered as an extension of Clinical Biochemistry. Global bodies on Laboratory Medicine such as the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), the Academy of Clinical Laboratory Physicians and Scientists (ACLPS), and the International Federation of Clinical Chemistry (IFCC) [13, 14, 15] have proposed different training programs in LM. However, the courses are yet to receive global acceptance, except the CP and AP-CP courses of the USA. Further, medical undergraduates remain almost completely unaware of Laboratory Medicine as a department or as a postgraduate discipline. In this context, the World Health Organization has set guidelines for the final year medical students [16] to develop knowledge and skills for running the medical laboratory.