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Clinical Biochemistry

The Department of Clinical Biochemistry offers 24-hour diagnostic support services to the physicians of our hospital. The laboratory is well equipped with state–of-the-art analyzers and technology and is focused on providing laboratory tests to benefit patient care.
 
The Clinical Biochemistry Laboratory provides an extensive range of testing services to all departments of the hospital by analysing parameters which include routine chemistry tests, multiple immunoassays – hormones, specialised endocrine testing, tumour markers, therapeutic drug monitoring, specific proteins, Down’s screening markers, heavy and trace metals, and some more special assays in blood, urine and other body fluids.
 
Diseases commonly encountered like diabetes mellitus, Cardiovascular disease, infertility, thyroid disorders, Kidney disorders, liver & pancreatic disorders, cystic fibrosis, meningitis, etc can be diagnosed by the examination of blood, urine and other body fluids. These test results are used not only for diagnosing health problems but also for screening & monitoring disease, for prognosis and in guiding the treatment of a patient. Quick processing is done for STAT samples and critical results are informed immediately.
 
State-of-the-art Technology
 
The Clinical Biochemistry Laboratory employs advanced automated equipment operations with the latest technologies, test methods and computer technology that support both routine and urgent testing.
 
The new technology CCM – Cobas Connecting module, connecting the preanalytics and the analytics for Lab automation was installed in February 2019, which has improved the TAT for the routine Chemistry tests for OP and IP. Introduction of cutting-edge technologies is an ongoing process in this department and together with faculty and technicians, accurate, dependable and quality results are delivered with quick turnaround time while maintaining a high degree of quality control. The advanced methods and technologies in use produce a high level of sensitivity and accuracy, diminishing the chance of human error, while yielding reliable results so that good care can be provided to the patient. The lab’s efficient systems enable routine testing on a single tube of blood of a patient for more than 40 different tests.
 
The department is open and enthusiastic towards introducing new tests. With the laboratory’s level of modernization, new tests are part of the routine work, conducted in our lab. Each test has passed through validation and performance qualification procedures that ensure accurate and consistent results, before introduction.
 
Continual initiatives in the development of automation of equipment and specimen handling over the years have made it possible to handle over 7000 samples per day and well over 28000 tests per day and on average perform more than 5.5 lakh tests a month.
 
Laboratory computerisation
 
The laboratory is computerised to maintain quality throughout all the stages of laboratory workflow. All the automated instruments are linked to the Hospital LAN allowing online transfer of results. The middleware IT3000 was introduced in 2014 in our lab followed by the introduction of Cobas Infinity software in 2022, connecting all of the automated instruments has improved the data management and helped with added features that have facilitated better results review and error identification, validation and delta check.
 
Quality control
 
The department recognises that maintaining a standard with accurate results and efficient turnaround times is crucial for effective treatment of our patients. Every step of the workflow, from sample receiving to reporting, and every parameter and analyser operated in the laboratory has an SOP (standard operating procedure) which is documented, to avoid inaccuracies due to deviant processing.
 
Commercial Internal quality controls and in-house QC samples are incorporated into the daily routine for each test which ensures that test systems and reagents are performing well. The QC values are recorded and reviewed periodically.
 
In addition, the laboratory participates in more than 16 different External Quality Assurance Scheme (EQAS) programmes which cover most of the accredited tests. Quality control and Quality assurance are held with high regard in the lab. Quality indicators such as turnaround time, sample rejection rate and test repeat rate are routinely monitored. The laboratory has been accredited by the NABL under ISO/IEC 15189 since 2002. At present, we have a repertoire of 200 parameters, out of which 155 are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
 
Faculty and technical staff
 
The Head is supported by the Quality and technical team who are competent, efficient, enthusiastic, and dedicated staff involved with routine lab testing, teaching and research. A Quality manager who is passionate about the implementation of laboratory Quality management systems that encompass all aspects of the testing process: preanalytical, analytical, post-analytical and as well for providing quality reports within the shortest possible time using the state of art equipment and standard methods. The technical manager oversees the troubleshooting of the analysers in the laboratory.
 
Faculty and senior technical personnel participate actively in continuing education programmes, external and internal, that expand their professional knowledge base and which also contribute to their work in the laboratory. The faculty members are given opportunities and are encouraged to facilitate projects from medical postgraduates of other departments or collaborate with other departments besides their routine work and teaching.
 
The department is dynamic and dedicated to excellence within the field of Clinical Biochemistry. The daily schedule makes Clinical Biochemistry a stimulating, challenging and enjoyable profession.
 
The department has four major roles i.e.
 
• Patient-care related diagnostic services
• Academic teaching
• Outreach programme – CMC EQAS
• Research activities

The Department of Clinical Biochemistry provides a 24-hour service to the clinicians of our hospital and to a smaller extent, services are extended to the mission hospitals and to any hospital Laboratory in the country which request for any of the special test available in our list.
 
A daily workload of 7000 samples and 28000 tests are handled by various automated systems and special manual assays which are monitored by 35 technologists trained in the laboratory and 11 biochemists (PhD, MD, MSc) who serve as faculty of the department. The testing scope includes nearly 155 accredited parameters measured using state-of-the-art technology.
 
Assays are done in blood, urine, body fluids and also tissues.
 
Routine serum and urine chemistry
 
  • Liver function tests, renal function tests and electrolyte profiles, lipid profiles, pancreatic function tests, Glucose, etc, which are analysed using automated random access discrete selective chemistry analysers. 
  • Urine qualitative analysis 
Immunoassays

  • Evaluation of endocrine organ function, fertility and reproductive disorders, growth and development. Hormones for assessing the thyroids, parathyroids, adrenals, pituitary, pancreas, reproductive system, therapeutic drug monitoring (anti-convulsants) 
  • Cardiac and bone markers 
  • Diagnosis and monitoring of tumour markers 
  • Special assays of Auto antibodies, markers for diabetes, IgE, inflammatory markers, Vitamin D, B12 and Folate, Sex Hormone Binding Globulin, Erythropoietin, and Anti-Mullerian hormone. The techniques used are ELISA, chemiluminescence, electrochemiluminescence, ELISA and TRACE.
Special test
 
  • Electrophoresis of serum and urine is done using capillary and gel electrophoresis. The panel consisting of serum protein electrophoresis, high-resolution urine electrophoresis for detection of Bence Jones protein, Immunofixation electrophoresis, serum Immunoglobulins, and estimation of free light chains in serum provides a detailed picture for Myeloma workup. 
  • Biochemical Markers for Down’s Syndrome
  • HbA1C, Antibodies to Islet cell antigens, GAD, and fructosamine are available as a panel to assess diabetes patients.
  • ELISA’s: Urine metanephrine, Intrinsic factor ab, Parietal cell, cANCA, pANCA etc.
  • Osmolality of serum and urine 
  • Stone analysis 
  • Sweat Chloride 
  • Special immunoturbidometric assays 
Highly special assays
 
  • Heavy metals such as Lead, Arsenic, cadmium, cobalt, chromium and heavy metal screening can be quantitated using the technique, of inductively coupled plasma–mass spectrometry. Trace metals such as Copper and zinc can be estimated at very low concentrations on Atomic Absorption spectrophotometry. Patient samples – serum, urine, tissues, occupational health monitoring and contamination of pharmaceutical preparations, water, etc can be analysed. 
  • Vitamins C, Organo phosphorus compounds on HPLC 
  • Steroid panel – Androstenedione and cortisone as projects on LCMS
 
Urgent (STAT) tests include:
 
  • Glucose,
  • Electrolytes
  • Calcium/phosphorus
  • Urea/creatinine
  • LFT
  • Amylase
  • Lipase, ammonia
  • Lactate
  • Anticonvulsant drugs
  • Procalcitonin
  • Bilirubin for neonates
  • Pseudocholinesterase
  • CSF- protein and glucose
  • Ascitic fluid (AF) and pleural fluid (PF)- protein and glucose
  • Cardiac markers – Troponin, CK-MB mass, myoglobin.
  • Tests like E2, P4, HCG and LH for Reproductive Medicine are carried out with prior arrangement.
 
The list of tests along with the methodology, reference intervals, specimen required and frequency of analysis are available in an annexure. Quality of the results is ensured by frequent analysis of precision controls (IQC) within the day and participating in external quality assurance schemes (EQAS). All the chemistry tests inclusive of serum & urine, all immunoassays, autoimmune markers and G6PDH are covered in BioRad -EQAS, RCPA –EQAS and CMC EQAS monthly programmes. The drugs, cardiac markers and special proteins are enrolled in specific schemes offered by Randox Laboratories, RIQAS.

OUTREACH PROGRAMMES

Our service to the nation is through conducting a
Proficiency Test scheme for Clinical Biochemistry  parameters 
 for  around  13,500  laboratories of the country and also
providing them with internal controls at an affordable cost.  CMCEQAS,
Clinical  Biochemistry is the first PT provider in the country for medical
lab testing. This is the 46th
year
of the CMC EQAS.

 

As part of this program the senior faculties of the
department have personally visited many laboratories throughout India. They
have given training on lab activities as well as suggestions for improvement in
performance. The goal has been to make an impact at the grass root level and
cover all strata, not only the urban labs but more importantly the semi urban
labs which cater to the rural population. These efforts have resulted in
creating a significant awareness among lab personnel on quality assurance (QA)
& quality control (QC) towards delivering reliable lab reports for
diagnosis of disease and subsequent monitoring.

The CMC-EQA, Clinical  Biochemistry 
is  accredited since 2014 by NABL as per ISO/IEC  17043:2010


1)  External Quality
Assurance Scheme (EQAS) at the National Level


Towards
determining inter-laboratory comparison of performance, Dr. Kanagasabapathy,
Dr. Peter Hill and Dr. Swaminathan carried out a pilot study in 1977 for some
laboratories and recognized the need to conduct such a programme  at the
national level, as this study revealed alarming variations in the results
reported. In 1978, in order to bring about improvement in laboratory services,
the Association of Clinical Biochemists of India (ACBI) constituted a “Quality
Control” committee under the Chairmanship of Dr. A.S. Kanagasabapathy. The
CMCH-ACBI External Quality Assessment Scheme (EQAS) was thus implemented in
1978 starting with 50 participant labs, with the valuable support and
encouragement from CMC management. Since then the department has been sending
regularly QC samples and giving feed back to the participating laboratories
based on their performance.

The participants represent all the states of India and from  neighbouring
countries. They include laboratories of large teaching and non-teaching
hospitals as well as corporate / private laboratories in urban areas and small
laboratories in rural areas. The number of participating labs have increased to
1

3,500 in the current year 2024, with 12
different programs. Many laboratories are benefited by this program, since it
is affordable compared to other commercially available EQAS scheme. 

For
more details please visit the EQAS web site at http://home.cmcvellore.ac.in/clinqc/ 
As part of this programme, we conduct
workshop/training for laboratory technicians.  

The Faculty of the Department of Clinical Biochemistry are involved in teaching as part of the following undergraduate and post-graduate programs:
 
Undergraduate Allied Medical Sciences   
 
B.Sc. Medical Laboratory Technology (MLT), a three-year course under The Tamil Nadu, Dr MGR Medical University, covering all aspects of Medical Laboratory Sciences, including Clinical Biochemistry. Theory and practical classes for Clinical Biochemistry are conducted for all the 3 years. The department has developed innovative methods to teach students as effectively as possible.
 
Postgraduate, Super-speciality, and Fellowship programms
 
Medical Postgraduates from various clinical specialities of the hospital undergo short-term or long-term posting in the department. The posting depending on the course includes laboratory practical work, lectures on major Clinical Biochemistry topics, demonstrations of the function of the analysers, principles of Quality management and as well participation in the departmental Journal Club.
 
  • MD Biochemistry – 7 months posting at the department with hands-on experience in every section of the laboratory. 
  • PG. Diploma in Clinical Pathology – 3 months posting. 
  • MD Pharmacology, Microbiology, Nuclear Medicine – 2 weeks.
  • DM in Rheumatology, Nephrology, Hematology, Endocrinology, – 1 week. 
  • Post-Doctoral Fellowship in Clinical Immunology & Rheumatology, Endocrinology -1 week. 
  • MD Physiology, MCH Endocrine Surgery – 1 day.
  •  
Laboratory training programmes:
 
  • One-month Internship training for the B.Sc. MLT after graduation: The students are posted in each section of the lab and are taken through various discussions with members of our faculty to have an understanding of the principles and methods involved in performing basic lab tests. They are also given hands-on training to be able to apply this knowledge in their future work as healthcare professionals. 
  • Clinical Biochemist in-house training program for B.Sc. graduates who have joined the department on a need basis. 
  • On-going training programmes for all the technical staff of the department: Training programmes for technicians include an academic nature and practical approach to troubleshooting, the importance of QC and maintenance of the analysers to develop them into competent healthcare professionals.
  •  Additionally, the department trains visiting MSc. students from VIT another neighbouring academic institution, and colleges in and around Vellore district for a month.
  •  Medical PG students from other medical colleges come as visitor-observers for up to 3 days.
 
Laboratory visits (up to 3 days):
 
  • Diploma Fellowship in diabetes
  • Distance education in diabetes, Intensive doctors training program at the secondary level in diabetes. 
  • One-day laboratory visit for the Laboratory Technology students from Scudder Memorial Hospital and SIH-R & LC Karigiri.

PhD programme:
 
Members of the faculty in the department are recognized as guides / co-guides by the Tamilnadu Dr. MGR Medical University to supervise our faculty staff and PhD students from other departments who have registered for PhD.
 
Training Programmes for WHO and ICMR-sponsored candidates
 
The department has run short training programmes (2-3 months) to meet the needs of MD and other candidates from within India and from overseas eg Malaysia, and Maldives in quality assurance and external quality assessment programmes and laboratory technology about immunoassays and automated chemistry analysers.
 
Work Experience visits of MRCPath candidates from UK Laboratories
 
Two candidates have been to our laboratory for approximately 6 weeks each, involving familiarization for them with a non-Western laboratory, presentations by the candidates and involvement in a laboratory-based project. The candidates produced a written report of their visit.

RESEARCH 

One of the activities of the department in addition to rendering laboratory services,
teaching programmes, etc, is its involvement in research. There are 
faculty doing part time research towards their Ph.D degree. The department
encourages research activities and many projects are taken up with medical PG
students of various other clinical departments, assays for clinical trials and
active collaborative studies with other departments and organizations are in
place. 

The department supports those seeking to do
research within the institution (or government organizations) in clinical
trials and multi-centric evaluations of new testing materials that fall within
the laboratory’s testing scope and also assessment of new analytes requested by
our clinicians. 

1) Former in service part–time PhD candidates:

  • Karunanaithi 
                –
    1981
  • Geetha Krishna 
            – 1992
  • Sri Krishna 
                  – 1993
  • S.
    Swaminathan         – 1995
  • B. Poonguzhali
             – 1999
  • Geethanjali  F.
    S        – 1999
  • Victoria
    Job              
     – 2000
  • Charles
    Stephen          – 2000
  • Pamela Christudoss
       – 2010
  • Arun Jose
    Nellickal    – 2015

·       
Joseph Dian Bondu    – 2018 

·       
Vanitha S                    – 2023

Professor (NM)

Associate Professor (NM)

Assistant Professors

Contact Information

Address :

The Head 

Department of Clinical Biochemistry 

Asha building 6th Floor

Christian Medical College Vellore

Ida Scudder Road, Vellore – 632004

Tamil Nadu, India 

Email us :

clinbio@cmcvellore.ac.in

Reach us :

04162282170

Working hours :

Mon-Fri: 8 am to 4.30 pm

( Sat : 8 am to 12:30 pm)