Ordinance Governing

M.Sc. MLT Course

Regulations and Curriculum

2006

Rajiv Gandhi University of Health Sciences, Karnataka4th 'T' Block, Jayanagar, Bangalore - 560 041

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Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore

The Emblem

The Emblem of the Rajiv Gandhi University of Health Sciences is a symbolic

expression of the confluence of both Eastern and Western Health Sciences. A

central wand with entwined snakes symbolises Greek and Roman Gods of Health

called Hermis and Mercury is adapted as symbol of modern medical science. The

pot above depicts Amrutha Kalasham of Dhanvanthri the father of all Health

Sciences. The wings above it depicts Human Soul called Hamsa (Swan) in Indian

philosophy. The rising Sun at the top symbolises knowledge and enlightenment.

The two twigs of leaves in western philosophy symbolises Olive branches, which

is an expression of Peace, Love and Harmony. In Hindu Philosophy it depicts the

Vanaspathi (also called as Oushadi) held in the hands of Dhanvanthri, which are

the source of all Medicines. The lamp at the bottom depicts human energy

(kundalini). The script “Devahitham Yadayahu” inside the lamp is taken from

Upanishath Shanthi Manthram (Bhadram Karnebhi Shrunuyanadev…), which

says “May we live the full span of our lives allotted by God in perfect health”

which is the motto of the Rajiv Gandhi University of Health Sciences.

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Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

Vision Statement

The Rajiv Gandhi University of Health Sciences, Karnataka, aims at bringing about a confluence of both Eastern and Western Health Sciences to enable the humankind “Live the full span of our lives allotted by God in Perfect Health”

It would strive for achievement of academic excellence by Educating and Training Health Professionals who

Shall recognize health needs of community, Carry out professional obligations Ethically and Equitably and in keeping

with National Health Policy,

It would promote development of scientific temper and Health Sciences Research.

It would encourage inculcation of Social Accountability amongst students, teachers and

Institutions.

It would Support Quality Assurance for all its educational programmes.

Motto

Right for Rightful Health Sciences Education

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CONTENTS

Table of Contents Page

Emblem i

Vision Statement ii

Notification iii

Section I Regulations Governing M.Sc.MLT course 5

Section II Aims and Objectives 19

Section III Course Content 20

I Year 20

1. Biochemistry-I 20

2. Microbiology-I 25

3. Hematology and Blood Transfusion -I 33

II Year 44

1.Biochemistry-II 44

2. Microbiology-II 54

3. Hematology and Blood Transfusion –II 63

Section IV Monitoring Learning Progress 74

Section V Ethics in M.Sc. MLT 84

Section VI Minimum requirement 86

Annexure I Bio-Medical waste management 92

SECTION -I

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Regulations Governing M.Sc.MLT course

1. Title of the Courses

Master of Science degree in Medical Laboratory Technology Course, M.Sc. (MLT) is

available in the following three branches:

a) M.Sc.MLT in Clinical Biochemistry

b) M.Sc. MLT in Microbiology &Immunology

c) M.Sc. MLT in Haematology & Blood Transfusion

2. Duration of the Course

The duration of the course shall be on full time basis for a period of two years from the

commencement of the academic term.

3. Eligibility for Admission

a) A pass in B.Sc. MLT Course from institutions affiliated to RGUHS, or from other

Universities considered equivalent by RGUHS.

b) Candidates passing B.Sc. MLT through correspondence course shall not be eligible

4. Selection Criteria

Selection shall be based on merit in the qualifying examination. The candidate has to

choose the branch of his /her choice during the time of seat selection. No change of

branch will be Permitted once he /she get admitted.

5. Eligibility certificate

No candidate shall be admitted for the postgraduate degree course unless the candidate

has obtained and produced the eligibility certificate issued by the university. The

candidate has to make the application to the university with the following documents

along with the prescribed fee.

Pass / degree certificate issued by the university.

Marks cards of all the university examinations passed.

Migration certificate.

Certificate of conduct.

Proof of SC/ST or category-I as the case may be.

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Candidates should obtain the eligibility certificate before the last date for

admission as notified by the university.

A candidate who has been admitted to post-graduate course should register

his/her name in the university within a month of admission after paying the

registration fee.

6. Medium of instruction

English shall be the medium of instruction for the subjects of study as well as for the

Examination.

7. Course of study

The course shall be pursued on full time basis. There are three branches in M.Sc MLT

course. However, both study and examination for main and subsidiary subjects in first year

shall be common to all the three branches. In the second year the student shall study subject

of his/ her chosen branch. Students shall be posted to RGUHS approved hospitals or clinical

laboratories during the practical hours.

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Subjects for study and teaching hours for first year and second year M.Sc MLT course are

shown in Table – I and Table-II respectively.

Table - I Distribution of Teaching Hours in First Year M.Sc. MLT Subjects

Sl.No. Main Subjects Theory

No. of hours

Practical

No. of hours

Total

1. Biochemistry-I

a. Clinical Biochemistry

b. Biomedical Techniques

c. Laboratory Management

80

40

40

120

40

--

320

2. Microbiology -I

a. Clinical Microbiology

b. Immunology

c. Molecular Biology

80

40

40

100

40

20

320

3 Hematology and Blood

Transfusion -I

a. Haematology & Clinical Pathology

b. Immunopathology

c. Medical Genetics

100

40

20

100

40

20

320

Subsidiary subject:

a. Biostatistics

b.Research methodology

30

20

10

--

40

20

Total 530 490 1020

Note: Main and Subsidiary subjects are common in I year for all the three branches.

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Table- II Distribution of teaching hours in Second year M.Sc. MLT subjects for the branches.

Sl.No Branches Theory

No. of hours

Practical

No. of hours

Total

1. Biochemistry-II 360 720 1080

2. Microbiology –II 360 720 1080

3. Haematology and Blood transfusion -II 360 720 1080

8. AttendanceEvery candidate should have attended at least 80% of the total number of classes

conducted in an academic year from the date of commencement of the term to the

last working day as notified by university in each of the subjects prescribed for that

year, separately, in theory and practical. Only such candidates are eligible to appear

for the university examinations in their first attempt. A candidate lacking the

prescribed percentage of attendance in any subject either in Theory or Practical in the

first appearance will not be eligible to appear for the University Examination in that

particular subject.

The course shall be pursued on full time basis. No candidate shall be permitted to work in

a nursing home or laboratory outside the institution while studying the course. No

candidate shall join any other course of study or appear for any other examination

conducted by this university or any other university in India or abroad during the period

of study.

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9. Monitoring Progress of Studies

Work Diary/Record Book Every candidate shall attend symposia, seminars,

conferences, journal review meetings & lectures during each semester as prescribed by

the department and not absent himself/herself from work without valid reasons. Every

candidate shall maintain a work diary and record of his/her participation in the training

programme. (Refer section III for model check lists and record book). Special mention

may be made of the presentations by the candidate as well as details of laboratory work

conducted by the candidate. The work diary and record shall be scrutinized and certified

by the concerned faculty members.

Internal Assessment (IA)

Institutions running the course shall conduct three tests each in First and Second year for

Internal Assessment. The third test shall be conducted one month prior to the university

examination so that it also serves as preparatory examination. The marks obtained in

these tests will be considered for internal assessment. Average of the best two marks will

be computed for internal assessment and shall be sent to the university as per the

notification issued by Registrar (Evaluation) before each university examination.

Records and marks obtained in tests will be maintained by the college and made available

to the university. Marks of periodic tests shall be displayed on the notice board by the

principals without fail.

If a candidate is absent from the test due to genuine and satisfactory reason, such a

candidate may be given a re-test within a fortnight.

The distribution of marks for internal assessment for subjects of study in first year and

second year are shown in Tables III and IV respectively.

Table III. Distribution of Internal Assessment marks in first year M.Sc.MLT course

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Sl No Subjects Biochemistry-I

Marks

Microbiology-I

Marks

Haematology &

Blood Transfusion-I

Marks

1.

Theory

20 20

20

2. Practical

Practicals- 15

20 Record - 5

Practicals-15

20 Record - 5

Practicals-15

20 Record - 5

Table IV. Distribution of Internal Assessment marks in second year M.Sc.MLT course

NOTE: A student must secure at least 50% of total marks fixed for internal assessment for a particular subject in order to be eligible to appear in university examination in that subject. The internal assessment marks will not be added to the marks obtained in the university examination for declaration of pass.

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Sl

No

Subjects Biochemistry-II

Marks

Microbiology-II

Marks

Haematology &

Blood Transfusion-

II

Marks

1. Theory

Paper-I

Paper-II

20

20

20

20

20

20

2. Practical

Practicals- 15

20 Record - 5

Practicals-15

20 Record - 5

Practicals-15

20 Record - 5

10. Dissertation

Each candidate pursuing M.Sc. MLT Course is required to carry out dissertation work on

a selected topic under the guidance of a recognized post graduate teacher for a period of

one year after the submission of synopsis. The results of such a work shall be submitted

in the form of dissertation.

The dissertation is aimed to train in research methods and techniques. It includes

identification of problem, formulation of hypothesis, search and review of literature,

getting acquainted with recent advances, collection of data, critical analysis,

interpretation of results and drawing conclusions.

Every candidate shall submit to the Registrar (Academic) of the University in the

prescribed proforma, two hard copies of synopsis along containing particulars of

proposed dissertation work within six months from the date of commencement of the

course or on or before the date notified by the University. The synopsis shall be sent

through proper channel.

The University shall arrange for review of synopsis and if found suitable shall register the

dissertation topic. No change in the dissertation topic shall or guide shall be made

without prior approval of the University.

The dissertation shall be written under the following headings:

Introduction

Aims or objectives of study

Review of literature

Materials and methods

Results

Discussion

Conclusion

Summary

References

Tables

Annexure

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The written text of dissertation shall not be less than 50 pages and shall not exceed 100

pages excluding references, tables, questionnaires and other annexure. It should be

neatly typed in double line spacing on one side of paper (A4 size, 8.27” x 11.69”) and

bound properly. Spiral binding should not to be done. A declaration by the candidate

that the work was done by him/her shall be included. The guide, head of the department

and head of the institution shall certify the bonafide of the dissertation.

Four copies of dissertation shall be submitted to the university through proper channel

along with a soft copy (CD), three months before the final examinations. It shall be

assessed by two examiners appointed by the university, one internal and one external. No

marks shall be awarded for dissertation. Acceptance of the dissertation is a pre-requisite

for a candidate to be eligible to appear in the final examination.

11. Guide

The eligibility academic qualification and teaching experience required for

recognition as Guides by the RGUHS are:

a) Eligibility to be a guide Shall be a full time teacher in the college or institution where he or she is working..

b) Academic qualification and teaching/professional experience for each branch

M.Sc. MLT- Clinical Biochemistry

Ph.D. in Medical Biochemistry / Clinical Biochemistry with minimum of three

years of teaching/professional experience after PhD in a teaching institution or in a

laboratory approved by RGUHS,

Or

M.D. in Biochemistry with three years of teaching/professional experience after

post graduation in a teaching institution or in a laboratory approved by RGUHS,

or

M.Phil. in Clinical Biochemistry with a minimum of four years of

teaching/professional experience after M.Phil in a teaching institution or in a laboratory

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approved by RGUHS,

or

M.Sc in Clinical Biochemistry [Medical], or M.Sc. MLT in Clinical Biochemistry

with five years of teaching/professional experience after the postgraduate qualification in a

teaching institution or laboratory approved by RGUHS.

M.Sc. MLT - Microbiology & Immunology M.D. or Ph.D. in Microbiology and three years of teaching/professional experience after post graduation in a teaching institution or in a laboratory,

or M.Sc. MLT in Microbiology and Immunology/M.Sc in Medical Microbiology with

five years of teaching/professional experience after the postgraduate qualification in a

teaching institution or laboratory approved by RGUHS.

M.Sc. MLT-Haematology & Blood Transfusion

M.D. or Ph.D. in Pathology and three years teaching/professional experience after

post graduation in a teaching institution or in a laboratory approved by RGUHS,

or

M.Sc. MLT in Haematology & Blood Transfusion with five years of

teaching/professional experience after the postgraduate qualification in a teaching

institution or laboratory approved by RGUHS.

c) Age:The age of guide shall not exceed 65 years. d) Student: Guide ratio - 5:1. A recognized guide shall supervise dissertation work of

not more than five students per academic year.

12. Schedule of examination

a. The University conducts two examinations in a year at an interval not less than four

to six months.

b. The number of examiners for practical and viva-voce shall be two, comprising of

one internal and one external examiner appointed by the university.

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c. A candidate shall not be admitted to the practical examinations for the first time

unless he/she produces the class record book certified by the Head of the

Department.

d. A failed candidate need to appear for both theory and practical examination in the

failed subject/s only in the subsequent examination.

13. Scheme of examination:

University examination:

There shall be two University examinations, one at the end of first year and the other at the end of second year, respectively.

First year M.Sc MLT

Both the main and subsidiary subjects for M.Sc. MLT course shall be common for all the

three branches in the first year.

Eligibility to appear in university examinationA candidate shall be eligible to appear for first year M.Sc.MLT examination at the

end of one year from the commencement of the course. He/She should have

satisfactorily completed the prescribed course and fulfilled the prescribed

attendance.

.

Written examination: Written examination shall consist of three theory papers each of three hours

duration. Each paper shall carry 100 marks.

Practical examination : There shall be one practical examination in each of first year subjects.

Each practical examination carries 100 marks.

Viva- voce : - This shall aim at assessing depth of knowledge, logical reasoning, confidence and

oral communication skills. Both internal and external examiners shall conduct the viva- voce. Total

marks shall be 50.

The particulars of subjects for examination and distribution of marks are shown in the Table –V.

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Table-V. Main Subjects for Examination and Distribution of marks for First year

Sl

No

Theory Practical Grand

TotalA Main Subjects No of

papers

Max

Marks

Practical

Marks

Viva –Voce

Marks

Total

Practical

MarksPaper I- Biochemistry-I

Section A: Clinical Biochemistry

Section B: Biomedical Techniques and

Laboratory Management

one

100 100 50 150 250

Paper II- Microbiology-I

Section A : Clinical Microbiology

Section B : Immunology and

Molecular Biology

one

100 100 50 150 250

Paper III- Haematology &

Blood Transfusion-I

Section A : Haematology and

Clinical Pathology.

Section B : Immunopathology and

Medical Genetics

one

100

100 50 150 250

B **Subsidiary subjects

Section A: Biostatatics

Section B :Research methodology

One

100

(60)

(40)

No practical examination 100

**Respective colleges shall conduct examination for subsidiary subjects and send the marks

to the University. Prescribed percentage of marks for a pass in subsidiary subject is 35.

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Second year M.Sc MLT

Examination in II year shall be held separately for each branch. A candidate will

appear only in the branch chosen by him/her at the time of admission.

Eligibility: To be eligible to appear in the II year examination a candidate shall have:

i) completed one year of study in II year, and ii) passed in all the subjects of I

year.

Written examination : Written examination shall consists of two theory papers. Each paper shall

be of three hours duration. Each paper shall carry 100 marks.

Practical examination : There shall be one practical examination in each of the branches . The

marks for each practical examination shall be 100 marks.

The duration of practicals from 9.00 a.m. to 5.00 p.m. with a lunch break of one hour in between

for each of the branches is as follows:

M.Sc. MLT Clinical Biochemistry II Practical 2 days

M.Sc. MLT Microbiology & Immunology II Practical 3 days

M.Sc. MLT Hematology & Transfusion II. Practical 2 days

Viva- voce : This shall aim at assessing depth of knowledge, logical reasoning, confidence & oral

communication skills. Total marks shall be 50. Presentation of dissertation and discussion on it be

done during the viva-voce .No marks shall be awarded to the presentation of dissertation.

Both internal and external examiners shall conduct the practical and viva- voce examination.

The particulars of subjects for examination and distribution of marks are shown in the Table –VI.

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Table-VI. Main Subjects for Examination and Distribution of marks for Second year

Sl

No Main Subjects Theory Practical

Grand

Total

No of

papers

Marks Sub

total

Practical

Marks

Viva –Voce

Marks

Total

Practical

Marks

1Biochemistry - II

Two

100

200 100 50 150 350

2 Microbiology-II

Two

100

200 100 50 150 350

3Haematology & Blood

Transfusion-II

Two

100

200

100 50 150 350

*Records –To be assessed by the external examiners during University Practical examination.

14. Criteria for Pass.

a. Criteria for pass in a subject:

For declaration of pass in any subject in the University examination, a candidate shall pass both in Theory and Practical examination components separately, as stipulated below:

Theory component consists of marks obtained in University Written paper. For a

pass in a theory subject, a candidate shall secure not less than 50% of maximum marks in

each paper and an aggregate of 50% marks per subject prescribed for the University

examination separately. For pass in practical examination the candidate has to secure

50% marks in aggregate i.e. marks obtained in the practical and viva-voce examination

added together provided the candidate has secured 40% marks in practical examination..

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A failed candidate is required to appear for both Theory and Practical in the subsequent

examination in that subject.

b. Criteria for pass in First and Second year: To consider as pass in first or second year a candidate has to appear in all the papers prescribed

for each subject and has to pass in all the prescribed subjects of the University examination for

the concerned year.

15.Carry over

A candidate who has appeared in all subjects of first year in the university examination is

eligible to go to second year provided he/she has passed in any two subjects. However, failed

candidate has to pass the failed subject to become eligible to appear for second year university

examination.

16 Declaration of distinction: A candidate securing total aggregate marks of 75% or more in the first attempt shall be declared as passed with distinction. Distinction will not be awarded for candidates passing the examination in more than one attempt.

17. Number of attempts

A candidate is permitted not more than three attempts (actual appearance) to pass the first year

examination or within two academic years from the year of admission, whichever is earlier. A

candidate will not be allowed to continue the course if he/she fails to comply with the above

stipulation.

18. Maximum duration for completion of course A candidate shall complete the course within four years from date of admission

Failing which the candidate will be discharged.

19. Eligibility for award of degree

A candidate shall have passed in all the subjects of first and second year to be eligible for award

of degree.

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SECTION II

AIMS AND OBJECTIVES

1. Aims and Objectives:

The goals of postgraduate training in various branches of M.Sc MLT are to train graduates who will:

Practice respective branches efficiently and effectively, backed by scientific knowledge and skill. Exercise empathy and a caring attitude and maintain high ethical standards. Continue to evince keen interest in continuing professional development whether in teaching or practice. Willing to share the knowledge and skills with any learner, junior or a colleague. To develop faculty for critical analysis and evaluation of various concepts and views & to adopt most rational approach.

Demonstrate understanding of basic sciences relevant to respective branches. Acquire the detailed knowledge about the fundamentals and advances of the

respective branches. Update knowledge by self-study and by attending courses, conferences and

seminars relevant to branch chosen. Undertake audit, use information and carryout research with the aim of

publishing or presenting the work at various scientific gatherings.

Acquire adequate skills and competence in performing various tasks as required.

Adopt ethical principles in all aspects of the professional practice. Foster professional honesty and integrity. Discharge the duties irrespective of social status, caste, creed or religion of the

customer/client. Develop oral and written communication skills. Provide leadership and get the best out of his or her team in a congenial working

atmosphere. Apply high moral and ethical standards while carrying out research.

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Be humble and accept the limitations in his or her knowledge and skill and ask for help from colleagues when needed.

Section III

Course Content

First Year M.Sc.MLT

BIOCHEMISTRY-I

THEORY :-

Section-A: - CLINICAL BIOCHEMISTRY 80 Hours

1. CHEMISTRY OF CARBOHYDRATES- Definition and Function- Classification- Isomerism of Monosaccharides- Properties of Monosaccharides- Modified Monosaccharides- Disaccharides- Polysaccharides

2. CHEMISTRY OF PROTEINS - Definition, function of Proteins- Classification of Amino acids- Properties of Amino acids- Classification and properties of proteins- Structural organization of proteins

3. CHEMISTRY OF LIPIDS- Definition and function of Lipids- Classification of Lipids- Properties of Lipids

4. NUCLEIC ACIDS- Nucleotides and its bases- DNA in detail

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- RNA and its classification- High energy compounds

5. ENZYMES- Classification of Enzymes- Factors affecting enzyme activity- Inhibitors- Specificity- Enzyme Kinetics- Enzymes in clinical diagnosis

6. Clinical significance, principle of estimation- Bilirubin General types and jaundice- Liver Function Test

i) Bilirubin estimation (Mally evlen method, jendrassrk and Gorf method direct spectrometry method)

ii) Alkaline phosphates and acid phosphates estimation by King’s methodiii) SGOT, SGPT Reatam frank method ALP, PT etc.

- Glucose tolerance test (GTT) importance and principle and techniques of GTT- Insulin tolerance test- Gastric juice analysis- Xylose absorption test- Analysis of calculi- Cerebrospinal fluid analysisi) Composition and function of CSFii) Clinical significance of CSF analysisiii) Estimation of sugar and proteins in CSF

7. Urine chemistry- Automation in Urine chemistry- Physical and Chemical examination of Urine samples. Qualitative tests for inorganic

urinary ingredients- Common qualitative and quantitative tests of urine- Clearance test for urine function

8. Electrolytes: sodium, potassium, chloride, CO2 (HCO3 -), total and ionized calcium, phosphorus (inorg.), magnesium.

9. Blood gases and pH, carboxyhemoglobin, CO, Met Hb, O2saturation

10. Disorders of carbohydrate metabolism

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11. Abnormalities of proteins in plasma

12. Disorders of plasma lipids and lipoproteins

13. Blood collection procedures- theory of anticoagulation.

Bio-Medical waste: Types, potential risks and their safe management.

CLINICAL BIOCHEMISTRY PRACTICALS 120 Hours1. Estimation of blood glucose by Folin method, Ortho toludine method & CHOD – POD

method.2. Estimation of protein by Biuret method, Lowry, UV method3. Estimation of serum creatinine by Jaffe’s method 4. Estimation of urea in blood sample by urease5. Estimation of Total cholesterol by CHOD/POD method6. Estimation of Triglycerides by GOP/PA method7. Estimation of HDL Cholesterol by precipitation method8. Estimation of SGOT in blood sample by kinetic method9. Estimation of SGPT in blood sample by kinetic method10. Estimation of alkaline phosphatase in blood sample by kinetic method11. Estimation of acid phosphatase in blood sample by kinetic method12. Estimation of bilirubin in blood sample by kinetic method13. Estimation of Na+, K+ & Ca++ by electrode analyzer14. Estimation of common parameters in urine through use of strips15. Estimation of T3, T4 and TSH by ELISA method.

Section B: -BIOMEDICAL TECHNIQUES AND LABORATORY

MANAGEMENT.

BIOMEDICAL TECHNIQUES 40 Hours

1. Methods of qualitative analysis of biomolecules:Principles, experimental procedures and application of chromatography – paper, thin-layer, ion exchange, affinity, gel filtration, gas-liquid and HPLC. Principles, procedures and application of Electrophoresis – paper, polyacrylamide gel, agarose gel, capillary and cellulose acetate.

2. Centrifugation Techniques – Principle and technique of preparative and analytical centrifugation, differential centrifugation, density gradient centrifugation, ultra-centrifuge and its application.

3. Quantitative methods: Principles and applications of Photometry, Spectrophotometry, flurometry, ion selective procedures, flame photometry, atomic absorption spectrometry. Ion selective electrodes and their applications in Medicine.

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4.Isotopes: Detection and measurement of radioactive isotopes, application of isotopes in research and clinical bio-cemsitry.5.Cell Fractionation, Biochemical activities of different fractions, marker enzymes.6.Bioenergetics and Biological oxidation: Concept of free energy change, high energy compounds, ATP generation, redox potentInternal Assesmentl, Electron transport chain, oxidative phosphorylation, inhibitors, Uncouplers, ionophores.7.Purification of enzymes from cells, characterization and criterInternal Assesment of purity, purification of proteins.

8. Bio-Medical waste: Types, potential risks and their safe management.

PRACTICALS ` 40 Hours

1. Chromatography: paper, thin layer, gel, ion-exchange, demonstration of HPLC and GLC2. Electrophoresis: slide gel, PAGE, Agarose gel, Native, SDS PAGE of Blood Sample.

(Demo only)3. Photometry, spectrophotometry, atomic absorption spectrophotometry4. Cell fractionation – methods

LABORATORY MANAGEMENT 40 Hours1. Preparation of operating budgets; general aspects of financial management of laboratories:2. Cost-analysis (tests and instruments); justification of providing new services or rejecting existing ones; lease and purchase decision analysis; delegation of budget responsibilities, work load statistics.3. Laboratory design: Designing laboratories for different types and sizes of institutions: selection of equipment and systems for the laboratory, concepts of workstation consolidation, workflow analysis, concepts in laboratory automation (sample transportation systems, modular systems, robotics).4. Laboratory safety: Fire, chemical, radiation and infection control(body substance precautions), hazardous waste and transport of hazardous materials.5. Training of technical staff: Familiarity is needed with the syllabi of various training programs; knowledge of the teaching requirements and level of knowledge technical staff; understanding of qualifications of technologists trained in other countries.6. Maintenance of records: Procedure manuals, ward manuals, quality control programs, patient data retrieval.7. Personnel management: Personnel policy manual; job descriptions; labor, supervision relations; conducting job interviews; motivation, recognizing job distress syndrome; delegation to a laboratory manager.8. Hospital organization; interactions between the laboratory service and the rest of the hospital.9. Professional ethics.10. Quality assurance; total quality management; development and monitoring of performance indicators.11. Public relations; hospital and community.12. Basic clinical epidemiology13. Laboratory Data Processing:

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14. General principles of methods for reduction of data into forms suitable for electronic data handling systems (computerized accessioning functions, sample identification and tracking (e.g. bar code systems), result reporting, storage and retrieval, electronic data transfer).15. Use of computers in quality control and management; use of computers for calculating analytical results (eg. non-linear functions).16. General aspects of system design; central vs. stand-alone systems, host computers and equipment interfaces.17. Laboratory information systems LIS), Hospital information systems (HIS).18. Personal computer use; word processing, spreadsheets, data-base, graphics, statistics, presentations, email, internet. Security of data storage and transmission.19. Data base structures and data mining.20. Appropriate access control to patient information.

SCHEME OF EXAMINATION OF BIOCHEMISTRY-I.

Theory: - Their shall be one paper of 3 hrs duration, carrying 100 marks each.

PAPER I:-Biochemistry-ISec A: - Clinical Biochemistry -50 marksSec B: - Biomedical Techniques and Laboratory Management -50 marks

Type of questions and distribution of marks for each section carrying 50 marks

Type of questions No of questions Marks for each questions

Total

Long Essay 01 20 20Short Essay 05 06 30

PRACTICAL EXAMINATION

Max Marks: 1001. Identification of Unknown Carbohydrate,

Protein or NPN - 30 Marks 2. Practicals: A - 40 Marks

Procedures involving Chromatography or Electrophoresis to be given for seperation and identification of aminoacids or carbohydrates.

Practicals: B - 30 Marks

2

Estimation of Glucose, Total protein, Creatinine, Urea, Cholesterol (any one)

VIVA-VOCE----50 Marks

The Viva Voce exam will carry 50 marks and both the internal and external examiners will conduct the examination

MICROBIOLOGY- I

THEORY:

Section A: - CLINICAL MICROBIOLOGY.

CLINICAL MICROBIOLOGY 80 Hours1. General aspects.The investigation of biological samples in infectious diseases is different from the other branches in that it requires general knowledge of pathogenic agents (bacteria or viruses) and of host reaction.

1.1 Definition of infection and infectious disease: natural bacteriological ecosystem.1.2 Pathogenicity of bacteria and viruses.1.3 General epidemiology of infection and infectious diseases.1.4 Sterilization & Disinfection1.5 Culture media and preparation1.6 Bacteriology of Milk, Water and Air

2. Diagnostic procedures.2.1 Specimen selection and collection (blood, urine, sputum, faeces, others).2.2 Specimen processing: smears, staining, cultures including cell cultures, susceptibility testing, antigen detection.2.3 Preservation of cultures2.4 Usual techniques for microbe and virus identification (including principal differential characteristics).2.5 Molecular biology techniques for characterization of microbes and viral agents.2.6 Bacteriological and viral serology.

3. Bacterial and viruses.Succinct description of responsible bacterial and viruses in bacteriological and viral syndromes or diseases (including principal differential characteristics).

3.1 Bacterial: Neisseria gonorrhoeae and N. meningitidis, Staphylococcus aureus, Coagulase Negative Staphylococcus, Streptococcus pyogenes (especially S. agalactiae and S. pneumonia), Escherichia coli, Salmonella, Shigella and other Enterobacteriaceae,

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Vibrio cholerae, Pseudomonas aeruginosa, Haemophilus influenzae, Clostridium perfringens, C. tetani, Bacteroides spp, Lister monocytogenes, Legionella, Mycobacterium tuberculosis and others, Treponema pallidum, Chlamydia, Mycoplasma, etc.Corynebacterium diphtheriae, Bacillus anthracis, B.cereus, Non sporing Anaerobes, Bordetella, Brucella, Yersinia, Actinomyces, Pasteurella, Franciesella,3.2 Viruses: herpes (herpes simplex, herpes varicellae, cytomegalovirus, Epstein Barr virus); hepatitis A, B, C, D, E; human immunodeficiency virus; enteroviruses (poliovirus); rubella, mumps, measles, parvovirus B19, RSV, myxovirus, rhinovirus, coronavirus, adenovirus, rotavirus, papillomavirus, rabies, Arboviruses, Poxviruses, Oncogenic Viruses,etc.

4. Antibiotics and antiviral agents5.1 Basic knowledge of antibiotics and antimicrobial therapy.5.2 Antibiotic and antiviral sensitivity test.5.3 Antibiotic and antiviral resistant mechanisms.

Medical Parasitology & Mycology5. Epidemiology, main clinical signs, basis for biological diagnosis (including a succinct description of parasites and fungi without biochemical characteristics),treatment.

5.1 Amoebiasis: Entamoeba histolytica.5.2 Giardsis, cryptosporidiosis and uro-genital trichomoniases.5.3 Malaria.5.4 Toxoplasmosis.5.5 Intestinal, hepatic and urinary helminthiasis: strongyloidiasis, ancylostomiasis, enterobiasis, ascariasis, schistosomiasis (Schistosoma mansoni and S haematobium), fascioliasis (Fasciola hepatica) and taeniasis (Taenia saginata).5.6 Fungal infections (Candida albicans, Cryptococcus neoformans, etc.).5.7 Aspergillus infections (Aspergillus fumigatus).5.8 Dermatophyte infections (Microsporum canis, Epidermophyton floccosum, Trichophyton rubrum, Trichophyton mentagrophytes).5.9 Leishmaniosis.5.10 Echinococcosis.5.11 Pneumocystosis.5.12 Filariasis.5.13 Leptospirosis

6. Usual techniques for parasite and fungus identification.7. Immunological and molecular diagnosis of parasitic and mycological diseases.

8. Bio-Medical waste: Types, potential risks and their safe management.

MICROBIOLOGY PRACTICALS 100 Hours

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1. Collection of clinical materials like blood, urine, stool, sputum,swabs, CSF etc.2. Parasitology - collection, preservation and transportation of faecal material for examination of parasites. Concentration techniques of stool for ova and cyst. Wet preparation of faecal sample for ova and cyst. Identification of ova and cyst in stool sample.3. Procedure of techniques of sputum for AFB.4. Procedure of skin clipping of Leprae Bacilli.5. Identification of organisms with Biochemical reactions of common organism like - Staphylococus, E.coli - Klebsiella, shigella, Salmonella, Proteus, Pseudomonas.6. Antibiotic Sensitivity tests7. Preservation of stock culture8. Bacteriology of water9. Collection of specimen for fungal examination like skin scrapings, swabs, CSF.10. Fungal examination by wet preparation11. Fungal culture12. ELISA HIV & HBsAg test (Demonstration only)13. Western blot test ( Demonstration Only)14. Incubation of fertile eggs and inoculation by various routes. (Demonstration only)

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Section B:-IMMUNOLOGY AND MOLECULAR BIOLOGY

IMMUNOLOGY 40 Hours

Immune System

Basic immunology A. Characteristics of the Immune System1. Define CD antigens.2. Define primary and secondary lymphoid tissues.3. Define mucosal-associated lymphoid tissues.

3.1 oral3.2 nasopharyngeal3.3 gut-associated3.4 reproductive

4. Describe blood-lymph circulation and lymphatics.5. Organization of lymph nodes

5.1 Explain hematopoietic cell distribution in lymph nodes.5.2 Provide examples and locations of lymph nodes in head and neck.

Innate and Adaptive Immunity1. Define concepts of specificity and memory.2. Describe basic properties of innate immune cells.3. Describe basic properties of adaptive immune cells.

Physiochemical properties of innate immunity1. Physiological barriers2. Anatomical barriers3. Phagocytic/endocytic barriers4. Inflammatory barriers

Adaptive Immunity1. Define humoral immunity.2. Define cell-mediated immunity.3. Define T cells, T cell subsets, B cells, and plasma cells.

Antigens and Immunogens1. Define antigen and immunogen.2. Define relative antigenicity of macromolecules.

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3. Define and give example of antigenic determinants and epitopes.4. List types of antigens with examples.5. Define ‘Hapten’ and explain how they function in the immune system

Immunoglobulins (Igs)/Antibodies (Abs):1. source from B cells and plasma cells2. B cell/antibody/specificity relationship3. Describe structure of immunoglobulins:

3.1. Molecular components of Igs3.2 heavy and light chains3.3 variable and constant regions3.4 Define allotype, isotype, idiotype.

Classification of immunoglobulins1. Explain differences based on heavy and light chains.2. Describe functional properties of Ig classes.3. Describe evidence for number of antigenic determinants recognized by Igs.

T cells1. Describe classification of T cells (Th1, Th2, αβ and γδ T cells).2. Compare and contrast molecular and cellular features of T cell receptor (TCR) to B cells receptor (Ig molecule).3. Describe development of T cells in the thymus.4. Describe the genes’ rearrangement in TCR development.5. T cell-associated molecule - the TCR complex

5.1 CD3 molecules5.2 T cell signaling by CD3

6. Define αβ and γδ T cells, including6.1 tissue distribution6.2 differential functions of αβ and γδ T cell.

The Complement System1. Define the complement system and describe when and how it is used.2. Provide step-by-step examples of how complement works:2.1 the classical complement pathway2.2 the alternate complement pathway3. List representative infectious agents and products that activate complement.4. Describe biological effects mediated by complement.5. Describe the effects of complement on the immune system.6. Describe the significance of complement at oral mucosal surfaces.

Antigen Processing and Presentation1. Describe use as a function of T cell activation.2. Describe cells involved in antigen processing and presentation.

The Major Histocompatibility Complex (MHC)

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1. Describe gene nomenclature for MHC antigens.2. List the numbers of human MHC genes.3. Explain the tissue distribution of MHC antigens.4. Describe the structure of MHC Class-I and Class-II molecules.5. Describe, with examples, how peptide antigens are processed.

Cell-Mediated Immunity (CMI)1. Describe the cells involved in CMI and the role played in the immune response.2. Describe the mechanisms of tissue cell destruction by T cells.3. Describe concept of ‘Memory T Cell’.4. Define Natural Killer (NK) cell.5. Define ‘Super Antigen’ and give examples in disease.

Bio-Medical waste: Types, potential risks and their safe management.

IMMUNOLOGY PRACTICALS 40 Hours1. VDRL Tests2. Brucella Agglutination test3. Weil felix test (Demonstration only)4. Paul Bunnel test (Demonstration only)5. RA test6. CRP test7. TPHA8. ELISA9. ASLO10. WIDAL

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MOLECULAR BIOLOGY

MOLECULAR BIOLOGY 40 Hours

1. DNA: the support of hereditary informationStructure, types, coiling and supercoiling, topoisomerases, replication, satellite DNA. Organisation of Prokaryotic and Eukaryotic genome, chromosomes structure, number, sex chromosomes, human karyotype, methods for chromosome analysis, chromosome banding, FISH, CGH, Flow cytometry, Cell cycle, mitosis and meiosis.

2. Transcription and translation factors involved, RNA processing, types of RNA, genetic code, Lac operon, Tryptophan operon, regulation in eukaryotes, gene dosage and gene amplification, generation of antibody diversity.

3.Mutation spontaneous, induced, point mutation and silent mutation, frameshift mutation, physical and chemical mutagents, molecular basis, site directed mutagenesis, significance of mutagenesis, DNA repair, isolating mutants, Ames test.

4. Recombinant DNA technology: necessary elements – enzymes and vectors – plasmids, cosmids, bacteriophages, shuttle vectors, expression vectors, construction of rDNA and cloning strategies – various methods, genomic libraries (e.g. using phage vectors), cDNA libraries, introduction of rDNA into host – methods, restriction maps and sequencing.

5. Genetics in medicine: Hemoglobin and hemoglobinopathies, phenylketonuria, alkaptonuria, homocystinuria, Lesch-Nyhan syndrome, genetics of cancer, Down’s syndrome, Di-George syndrome, Kleinfelters syndrome, Turner’s syndrome, hermaphroditism, cystic Fibrosis, hemophilia, prenatal diagnosis of genetic diseases, application of recombinant DNA Technology in medicine – PCR, RFLP, DNA finger printing, therapeutic proteins, vaccines, antibodies, transgenic organisms, gene therapy, human genome project.

MOLECULAR BIOLOGY PRACTICALS 20 Hours

PCR- Side Directed MutagenesisDNA IsoltationDNA Cloning, Bacteriall Transformation and Fusion Protein Purification (Demonstration only)Plasmid Analysis by Restriction Digestion and Protein Gel ElectrophoresisDNA Gel Electrophoresis.

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SCHEME OF EXAMINATION Theory: - Their shall be one paper of 3 hrs duration, carrying 100 marks each.

PAPER II:- MICROBIOLOGY-I

Sec A: - Clinical Microbiology -50 marksSec B: - Immunology and Molecular Biology -50 marks

Type of questions and distribution of marks for each section carrying 50 marks

Type of questions No of questions Marks for each questions

Total

Long Essay 1 20 20Short Essay 5 06 30

PRACTICAL EXAMINATION:

1. Identification of bacterial culture (Pre plated Cultures on Mac Conkey or Blood Agar and if

required IMViC tubes to be provided) - 15 Marks

2. Spotters - 15 Marks

3. Stool Examination -10 Marks

4. Acid Fast Stain - 10 Marks

Or

Albert’s Stain

5. Serology Exercise - 30 Marks

6. Mycology Exercise - 20 Marks

Total - 100 Marks

Viva-Voca Examination 50 MarksBoth internal and external examiners shall conduct the practical and viva-

voce examination

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HAEMATOLOGY AND BLOOD TRANSFUSION –I

THEORY

Section A: - HAEMATOLOGY AND CLINICAL PATHOLOGY

HAEMATOLOGY 75 Hours

Haemotopoesis – Origin, development, function and fate of blood cells.Erythropoiesis – Origin, development of RBCs, biosynthesis of Hb, control of Erythropoiesis.Disorder’s of Red blood cells, Erythrocyte Indices, Red cell inclusion bodiesAnaemia, definition, Pathophysiology, classification -morphologic and Etiologic classification and clinical features. Investigations in a case of anaemia.Morphologic – Microcytic hypochromic anaemia, macrocytic anaemia.Haemolytic anaemias – Definition, classifiction, clinical features.Investigations to establish a case of hemolytic anaemia. Tests done - i. Peripheral smear – specific morphologic abnormalitiesii. Reticulocyte countCorrected reticulocyte countReticulocyte production indexiii. Osmotic fragility testiv. Coomb’s testv Sickling phenomenonvi. Kleihauer acid Elution testvii. Alkali denaturation testviii Ham’s test, Sucrose lysis Testix Electrophoresis – HbF & Hb A2 estimationx. Test for G6PD deficiency Aplastic anemia. Pancytopenia, Anemia due to abnormal globin synthesis Polycythaemia. Disorders of white Blood cells – Leucocytosis, Leukopenia, Leukaemoid reaction, Myelodysplastic syndrome(MDS) . Leukaemias -Definition ,Etiology ,Clinical features. Classification- [ French American British- FAB classification] Lab Investigations Cytochemistry of Acute leukaemias Chronic myeloid leukaemia -clinical presentation. Investigations. Philadelphia chromosome. Leucocyte Alkaline Phosphatase [LAP score.] Chronic lymphocytic leukaemia5. Plasma cell disorders – classification Plasma cell myeloma – definition ,clinical features, investigations.6. Myelo Proliferative disorders – general features ,classification – investigations 7. Lympho Proliferative disorders - general features, classification , Investigations

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8. Lipid Storage Disorders 9. Haemoparasites 10. Bone marrow examination11 Haemorrhagic disorders

Definition – Pathogenisis,Clinical fearture ,Classification. - vascular disorders, Platelet disorders, coagulation disorders, Fibrinolysis.

Normal haemostasis . Investigation of heamorrhagic disorders Tests of vascular and Platelet function – Bleeding time , Clot retraction, Platelet count B..M Aspiration , Platelet Aggregation Studies. Tests for Coagulation Disorders Screening test – First line tests Prothrombin time (PT), Activated Partial Thromboplastin Time(APTT), Thrombin Time (TT) Second line tests – Mixing experiments. Urea Solubility Test[Test for Factor XIII ] Coagulation Factor assay. Factor VIII: C Inhibitor Study. Disseminated Intravascular Coagulation [ DIC ]-Definition ,Pathophysiology, Clinical Feartures and Laboratory Investigations. Fibrinogen assay 12. Thrombotic disorders –Classification, Pathogenisis, Clinical Feartures and Laboratory Investigations. Antiphospholipd Antibody Syndrome.13. Automation in Haematology 14. Organization & quality control in the laboratory15. Cleaning of glassware16. Biomedical waste management

Bio-Medical waste: Types, potential risks and their safe management.

HAEMATOLOGY PRACTICALS 60 HoursBlood collection. Anticoagulants used in HematologyRed cell indicesE.S.R., PCV, Platelet count, Absolute Eosinophil countReticulocyte countStains used in HematologyPreparation of blood filmPreparation of Leishman’s stain, Giemsa stain and MGG stain Peripheral smear staining by leishman’s stain. Interpretation of peripheral smear. Differential count.Microcytic hypochromic anemia – Investigations including serum Iron & TIBCMacrocytic anemia - Investigations including B12 & folate assay, schilling test 9. Hemolytic anemia – General Lab investigations 10. Hemolytic anemia - Special Tests. Osmotic fragility test Alkali denaturation test Sickling test

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Hb electrophoresis Investigations of G6PD deficiency Autoimmune hemolytic anemia investigations Coomb’s test11. Blood Parasites12. Bone marrow – preparation of bone marrow smears , Trephine biopsy smears Staining of B.M Aspiration Smears. Demonstration of Iron stain13. Leukemia - Interpretation of Peripheral smear in Leukemia.Cytochemical stains – Demonstration14. Haemorrhagic disorders Collection and anticoagulants used – DemonstrationBT, CT – Demonstration PT,INR, APTT, TT- DemonstrationMixing experiments – Demonstration Test for D-Dimers- Demonstration Assay of coagulation factors - Demonstration Factor VIII: C Inhibitor Study – Demonstration Urea Solubility Test for Factor XIII- Demonstration Fibrinogen assay - - Demonstration 15. Thrombotic work up - Demonstration Investigation for Antiphospholipid Antibody- Demonstration 16. Automation in hematology - demonstration17. Cleaning of glassware 18. Bio-medical waste management – demonstration. 19. Organization and quality control in the laboratory.20. Preparation of Stains, Reagents, Diluting fluids.

CLINICAL PATHOLOGY 25 Hours

Collection, transport, preservation and processing of various clinical specimensUrine examination, Physical, chemical and microscopic. Urine analysis by Strip method Test for haemosiderin pigment. Renal function tests.Stool examination – collection of specimen of feacesMacroscopic (Naked eye) inspection ii Concentration method ,Flotation method . iii. Microscopic examination iv. Chemical examinationStrip method vi. Test for Occult blood – Benzidine TestSputum examination – collection of specimen i. Physical examination ii. Microscopic – Gram’s stain, Ziehl Neelsen stain for AFB iii. Chemical examination Gastric analysis

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Indications ,contra indication. Method of collection. Fasting gastric juice – Macroscopic and microscopic examination.i Fractional test mealii. Augumented Histamin test iii. Hollander’s testCerebrospinal fluid analysisMethod of obtaining CSF, indications, contra indications.Examination of CSF : i. Physical examination ii. Biochemical examination iii. Microscopic examination a. Cytological examination b. Bacteriological examination Body fluidsMicroscopic examination of Pleural, Pericardial, synovial, ascitic and peritonial fluid. Pregnancy Test- Method ,interpretation.

Bio-Medical waste: Types, potential risks and their safe management.

CLINICAL PATHOLOGY PRACTICALS 40 Hours

1.Urine examination, Physical, chemical and microscopic. Urine examination by Strip method Urine Test for haemosiderin pigment. [Demonstration ] 2. Stool examination – i. Macroscopic examination ii. Concentration method ,Flotation method . iii. Microscopic examination iv. Benzidine Test- for occult blood3. Sputum examination - Macroscopic, Microscopic and AFB Staining4. Examination of Cerebrospinal fluid [CSF ] and body fluids.5. Pregnancy Test 6. Examination of Semen.

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Section B: - IMMUNOPATHOLOGY AND MEDICAL GENETICS

IMMUNOPATHOLOGY 40 Hours1. Mechanism of Ab-mediated inactivation : direct and indirect

Eg. Diabetes mellitus, thyroid diseases, pernicious anemia, polyendocrinopathy, infertility, haemophilia, myasthenia gravis, anti-idiotypes and diseases.

2. Immune deficeincy disorders3. Immunohaematologic diseases : transfusion reactions, erythroblastosis foetails, warm-antibody

disesases, cold antibody diseases, drug and hemolytic diseases, agranulocytosis, thrombocytopenic purpura, immune suppression cytotoxic antibodies in vitro.

4. Immune comples reactions : arthus reaction, serum sickness, evaluation of circulating immune complexes.

5. Connective tissue diseases : Pl;arteritis, SLE, dermatomyosis, rheumatic fever, rhematoid arthritis, prograssive systemic sclerosis.

6. Atopic anaphyllactic reactions : reaginic antibody, anaphylaxis, atopic allery – factors involved, asthma, hay fever, food allergy, insect allergy, atopic eczma, delayed hypersensitivity reactions, contact dematitis, viral infectionss, graft-host relationship in pregnancy.

7. Autoallergiiic diseases: encephalomyelitis, multiple sclerosis, oorchitis, thyroiditis, sjogren’s syndrome.

8. Granulomatous reactions : Infectious diseases like tuberculosis, leprosy. 9. Autoimmune diseases-organ specific and systemic. 10. Immunomodulators 11. Clinical transplantation-Kidney ,Bone marrow ,Heart. 12. Immunology of AIDS ,Tumour and Tumour markers. 13. Immunohaematology- Campatibility testing.

Bio-Medical waste: Types, potential risks and their safe management.

IMMUNOPATHOLOGY PRACTICALS 40 Hours1. Serological tests [Screening &diagnostic] used in different pathological conditions. 2. Delayed type hypersensitivity testing. 3. Detection of tumor markers. 4. Histocompatibility testing.5. Blood grouping &cross matching. 6. Coomb’s Test - Direct & Indirect. 7. Setting up of Immuno histochemistry lab.

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MEDICAL GENETICS 20 Hours

1. The history and impact of Genetics in MedicineGregor Mendel and the laws of inheritance.The chromosome basis of inheritanceOrigin of Medical GeneticsClassification of Genetic diseaseThe impact of Genetic diseaseMajor new developments

2. The Chromosome varInternal Assesmenttion and sex determinationAn overview of chromosome number, chromosome composition and sex determination in humans. Methods of chromosome analysis.Molecular cytogenetics.Chromosome abnormalities.

3. Human genetic diseasesGenetic disorders with classical MendelInternal Assesmentn inheritance.Autosomal recessive inheritance.Patterns of autosomal dominant inheritance.X-linked inheritance.Patterns of pseudo-autosomal inheritance.A typical pattern of inheritance.

4. Biochemical geneticsThe inborn errors of metabolism.Disorders of amino acid metabolism.Urea cycle disorders.Disorders of carbohydrate metabolisms.Disorders of steroid metabolism.Disorders of lipid metabolism.Lysosomal storage disorders.Disorders of purine/pyrimidine metabolism.Organic acid disorders.Disorders of copper metabolism.Peroxidase disorders.

5. Human Genome project, treatment of genetic disease and gene therapy.

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Human genome projectTreatment of genetic diseaseGene therapy.

6. Genetics & society.

GENETICS PRACTICALS 20 Hours1. Study of Karyotypes INormal karyotyping in Humans – male (46, XY) and female (46, XX), G banded metaphase plates.

2. Study of Karyotypes IIAbnormal karyptypes – Down syndrome (Autosomal), Turner syndrome and Klinefelter syndrome (Sex chromosome)

3. Sex chromatinBuccal semear study and staining methods for Barr bodiesBlood smear study of drumsticks in neutrophils

SCHEME OF EXAMINATION Theory: - Their shall be one paper of 3 hrs duration, carrying 100 marks each.

PAPER III:- Haematology and Blood Transfusion -I

Sec A: - Haematology and Clinical Pathology -50 marksSec B: - Immunopathology and Medical Genetics -50 marks

Type of questions and distribution of marks for each section carrying 50 marks

Type of questions No of questions Marks for each questions

Total

Long Essay 1 20 20Short Essay 5 06 30

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Practicals Examination - Total –100 marks1. Spotters - 20 marks2. Staining and reporting the Peripheral smear - 20 marks3. Special test - ( Any two to be performed ) - 10marks

a. RBC / WBC Countb. Reticulocyte countc. Absolute Eosinophil Countd. ESR or PCVe. Osmotic Fragility Testf. Sickling test

4. Blood Transfusion preliminary testsa. Blood grouping and typing including Dn test (Compulsory ) - 10 MarksAny one of the following - 10 Marksb. Cross – Matching –

c. Coomb’s Test - Direct & Indirect5. Clinical Pathology a. Urine Examination (Compulsory) – 10 Marks

i. Physical ii. Microscopiciii. ChemicalAny two of the following - 10 Marks1.Sugar & Ketone Bodies2.Protein & Blood3. Bilirubin / Bile salt / Bile pigmentStool Examination - 10 Marksi. Microscopicii. Macroscopiciii. Special Tests

Viva-Voce Examination -50 Marks1. Haematology –152. Clinical Pathology – 103. Immunology – 15

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Both internal and external examiners shall conduct the practical and viva- voce examination

**SUBSIDARY SUBJECTS I YEAR

1. BIOSTATISTICS 30 Hours

1. Introduction to BiostatisticsDefinition, role of statistics in health science and health care delivery system 2 . Sampling Population, sample, sampling, reasons for sampling, probability and non-probability samplingMethods of probability sampling-simple random, stratified, systematic-procedure, merits and demeritsUse of random number table.3. Organization of data Frequency table, histogram, frequency polygon, frequency curve, bar diagram, pie chart4. Measures of location Arithmetic mean, median, mode, quartiles and percentiles – definition, computation (for raw data ), merits, demerits and applications.5. Measures of variationRange, inter –quartile range, variance, standard deviation, coefficient of variation- definition, computation (for raw data), merits, demerits and applications 6 : Basic probability distributions and sampling distributions: Concept of probability distribution. Normal, Poisson and Binomial distributions, parameters and application. Concept of sampling distributions. Standard error and confidence intervals. [Skewness and kurtosis ]7 : Tests of significance :

Basic of testing of hypothesis – Null and alternate hypothesis, type I and type II errors, level of significance and power of the test , p value.

Tests of significance (parametric) – t – test (paired and unpaired), Chi square test and test of proportion, one way analysis of variance.8 . Correlation and Regression :

Scatter diagram, concept and properties of correlation coefficient, examples (No computation Simple correlation ) Pearson’s and spearman’s, testing the significance of correlation coefficient. Linear and multiple regression.

Suggested books : 1. Lwanga SK Cho-Yook Tye (Editors). Teaching Health Statistics, Twenty lessons and

seminar outlines, World Health Organization, Geneva2. Mahajan BK, Methods in Biostatistics for medical students and research workers. 6 th

Edition, Jaypee Brothers medical Publishers, New Delhi, 1997.3. Sundr Rao PSS and Richard J. Introduction of Biostatistics; A Manual for students in

Health sciences. Prentic-Hall of India Pvt. Ltd, New Delhi.4. N.S.M. Rao : Elements of Health statistics

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STATISTICS PRACTICALS 10 Hours

1. Collection and tabulation of data2. Graphical representation of data3. Correlation and regression analysis4. Student’s ‘t’ test5. Chi-square test6. ANOVA

2. RESEARCH METHODOLOGY 20 Hours

AimThe aim of this Module is to provide the student with experience of researchmethods and techniques while working alongside research laboratory staff on a designated research project.

ObjectivesBy the end of this Study Module students should be able to:(i) design, carry out, write up and critically appraise a selected research topic;(ii) demonstrate knowledge of skills in appropriate research laboratory practices;(iii) carry out a range of laboratory techniques using appropriate methodologies.

ConstituencyThese module are intended for students who wish to learn research methods and techniques and perhaps do a PhD in the future. Some experience of laboratory practice would help the student to take full advantage of this module, although in most instances students will be fully trained in all necessary techniques.

Conceptual outlineThis is a purely practical module designed to introduce students to a variety of research techniques and to give them the opportunity of using these techniques in conducting a novel a research project. Each student will choose an individual research project and will be directly supervised by an expert in the field. This Module will necessitate long working hours in some cases and may involve some students studying at institutions other than the parent Institution.

Teaching strategyThis module is entirely laboratory based, with no formal teaching or lectures. Teaching is on a one-to-one basis with a designated supervisor. Students must be highly

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motivated and be prepared to work long hours in order to make a success of this module.

Reviewing the literature AimThis Study Module aims to describe and illustrate the methods available for identifying and reviewing quantitative and qualitative literature.

ObjectivesBy the end of the Study Module students should be able to:(i) carry out an appropriate, rigorous review of the literature; and(ii) understand the strengths and weaknesses of different methods of identifying, assessing and synthesizing literature.

Conceptual outlineThis module will cover all stages in carrying out an appropriate and rigorous review.1. Planning the review: the role of the literature review and specification of the task2. Identification of relevant literature, both published and unpublished: developing a search strategy and using bibliographic databases.3. Appraising the literature: methods for assessing the quality of quantitative andqualitative research.4. Synthesising the evidence: integration of the evidence using both quantitative and qualitative methods; principles of meta-analysis.5. Formulating recommendations and writing the review.

Teaching strategyThe technical aspects of literature reviewing will be presented in lectures and computer practicals, using some of the databases available through the RGUHS’s HELINET network. The format of the seminars will encourage both a practical application and critical appraisal of methods. Each student can choose his or her own topic and question for their assessed literature review. Students should consider possible topics and questions in preparation for the Study Module. There will be three sessions during the Study Module for general advice on the assessment.

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Course Content

Second Year M.Sc.MLT

BIOCHEMISTRY-II

PAPER ISECTION A1. LIVER AND BILIARY TRACT STATUS

The dynamics and mechanisms of liver enzyme release and the clinical utility of measuring hepatic enzymes (e.g., aspartate aminotransferase, alanine aminotransferase, -glutamyltransferase, alkaline phosphatase, and lactate dehydrogenase).

The biochemical assessment of liver function by nonenzyme analytes such as albumin, ammonia, bile acids, bilirubin, urea nitrogen, cholesterol, total protein, and triglycerides.

Bilirubin metabolism, fractionation of bilirubin (conjugated, unconjugated, -bilirubin, direct vs indirect) and unique aspects of neonatal bilirubin. Understand the conditions and genetic defects that affect bilirubin metabolism, transport and clearance (e.g., Gilbert disease and Dubin-Johnson syndrome).

Jaundice

2. RENAL FUNCTION

The basic physiology of renal function. The basic categories of renal diseases (e.g., pre renal azotemia, obstructive azotemia, glomerulonephritis, acute vs chronic renal failure, uremic syndrome) and be familiar with the National kidney Foundation practice guidelines for these conditions. The laboratory analytical methods (e.g., Jaffe vs creatinase) for the assessment of renal function (creatinine, urea nitrogen, glomerular filtration rate) and proteinuira. The concept of creatinine clearance, how it can be used to estimate glomerular filtration rate, and the various methods employed to measure it. Renal handling of electrolytes and key metabolites and the interpretation of urinary electrolyte measurements.

The definition of osmolality, molecules in serum that contribute to osmolality, and calculation of osmolal gap as well as the principle of the osmometer. The common pitfalls and sources of error during estimation of the osmolal gap (e.g., hyperproteinemia, hyperlipidemia, hypermagnesemia). The differential diagnosis of an unexplained, increased osmolal gap, including alcohol or glycol ingestion, alcoholic or diabetic ketosis or ketoacidosis, and osmotherapy (e.g., mannitol or glycerol administration), among others. The principles of fluid balance.

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3. GASTRIC & PANCREATIC FUNCTION

The clinical manifestations of gastric, pancreatic, and intestinal disease and diagnostic methodologies such as the breath tests for Helicobacter pylori, fecal occult blood, lipase and amylase (e.g., fractionation of amylase; pancreatic vs salivary and amylase/creatinine clearance ratio).

The role of gastrointestinal hormones and enzymes in digestion and the evaluation of malabsorption and diarrheal sydromes.

4. ASSESSMENT OF THYROID FUNCTION

The structure, biosynthesis, secretion, and metabolism of thyroid hormones (thyroxine (T4), triiodothyronine(T3), and reverse T3 (rT3). Thyroid physiology and control of thyroid function (thyrotropin-releasing hormone (TRH) and thyrotropin (TSH).

The common causes of hypothyroidism and hyperthyroidism The laboratory tests for evaluation of thyroid disorders and be able to interpret these

analytes in their clinical context with an apprecitation for the euthyroid sick state. Current analytical methodologies for thyroid testing (TSH methods : 1st-, 2nd-, and 3rd-

generation assays; isotopic and nonisotopic methods; T4; free T3 methods; T-uptake methods; TSH suppression and stimulation tests).

5. ACID-BASE CHEMISTRY WATER AND ELECTROYLTES BALANCE.

Define the Henderson-Hasselbach equation. Physiologic buffers systems and the role of respiratory and renal compensation. Categories of clinical disorders of acid-base balance (metabolic and respiratory acidosis, metabolic and respiratory alkalosis, mixed disorders).

The differential diagnosis of common electrolyte disorders

6. ISOENZYMES AND CLINICAL ENZYMOLOGY

7. TUMOR BIOMARKERS :

The definition, classification, biochemistry, and distribution of tumor markers, both protein and carbohydrate, including, but not limited to, prostate-specific antigen, calcitonin, human chorionic gonadotropin, -fetoprotein, carcinoembryonic antigen CA 15-3, CA 125, and CA 19-9.

The limitations of laboratory assessment of various tumor markers and the factors affecting the results of different analytical procedures.

The conceptual basis of assays used to screen for malignancy, including Bayes theorem.

. Recent developments in identifing proteomic patterns for cancer detection.

8. PEDIATRIC CLINICAL BIOCHEMISTRY

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Problems of specimen collection; capillary specimens. Reference range differences in infants and children: Those that vary significantly with age and sex (inorganic phosphorus, creatinine, alkaline phosphatase, aspartate aminotransferase, creatine kinase).Special problems in pediatrics: Respiratory distress syndrome , gastrointestinal disease (fat absorption, disaccharide intolerance, protein-losing neonatalhyperbilirubinemia; cystic fibrosis; neuroblastoma (VMA ,HVA); enteropathy), , Heavy metal poisoning in children.

9. AUTOMATION AND POINT OF CARE TESTING (POCT)

10. COLORI METER AND SPECTROPHOTO METER

11. FLAME PHOTO METER AND ION SELECTIVE ELECTRODES (ISE)

12. BLOOD GAS ANALYSIS

13. PH METER

14. ELECTROPHORESIS AND CHROMATOGRAPHIC TECHNIQUES

15. Therapeutic Drug Monitoring and Toxicology

SECTION B1. PHARMACOKINETICS The concepts of drug absorption, bioavailability, volume of distribution, and

distribution phases (multicompartment models) and be able to predict peak drug levels.

The differences between fist-and zero- order kinetics of drug metabolism / elimination.

The concepts of drug clearance, halt-life, and the exponential rate constant. Be able to calculate steady-state drug levels and estimate peak and trough drug levels throughout a dosing cycle

The origin and consequences of nonlinear or zero-order pharmacokinetics on drug pharmacokinetics

The differences between measurement of total, free, and protein-bound drug levels and be able to assess the consequences of altered protein binding on pharmacokinetics and therapeutic drug monitoring.

2. DRUG METABOLISM The differences between phase I and phase II drug metabolism reactions Various consequences of competing metabolic pathways to

modulate both the efficacy and toxicity of administered medications Frequent interindividual variability drug-metabolizing enzymes and its impact on the

variability of drug response

3. PHARMACODYNAMICS

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The general mechanisms of drug action, including drug-receptor interactions, modulation of metabolic pathways, and nucleic acid biochemistry.

Rreference ranges for therapeutic drug monitoring, methods of establishing the same and understand the varying utility of trough , peak, or steady-state drug levels for monitoring both drug efficacy and toxicity. The therapeutic index.

4. THERAPEUTIC DRUG MONITORING OF SPECIFIC DRUG CLASSES

The principles and practice of therapeutic drug monitoring of antidepressants, mood stabilizers, and antipsychotics; anticonvulsants; cardioactive drugs; bronchodilators; antibiotics; and immunosuppressants.

The relative significance of peak and trough levels for monitoring of these drug classes

5. TOXICOLOGIC SYNDROMES The pathophysiological basis and be able to recognize the five major toxicologic

syndromes (cholinergic, anticholinergic, sympathomimetic, opiate, and sedative-hypnotic).

formulation of toxicologic differential diagnosis and designing a clinical laboratory testing protocol for each of the syndromes

The basic therapeutic approach to each syndrome

6. LABORATORY EVALUATION AND MANAGEMENT OF OVERDOSED OR POISONED PATIENTS

The National Academy of Clinical Biochemistry guidelines for Emergency Toxicology.

The important differences between urine and blood (including serum and plasma) for monitoring and detection of drugs / xenobiotics.

Designing and implementing standardized STAT panels of laboratory tests for evaluation of overdosed/poisoned patients.

The limitations of drug "screening" protocols and be able to consult on the design of more extensive drug-testing protocols to supplement the standard STAT panels.

The toxicologic profiles of specific agents, including acetaminophen, salicylates, alcohols and glycols, barbiturates, tricyclic antidepressants, carbonmonoxide, organophosphates and carbamate, digoxin lead, iron, and cyanide.

The general supportive measures, the role of alkalinization, the importance of specific antidotes, and the variable efficacy of exchange transfusion hemodialysis, plasmapheresis, and charcoal hemoperfusion of blood in the management of specific agents.

7. LABORATORY EVALUATION OF DRUGS OF ABUSE

The generic methodology of the routine immunoassays for drugs-of-abuse testing. Major drugs of abuse and their clinical manifestations

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Common methods for adulteration of urine and the techniques available in the laboratory to detect them.

Specific reactivates of each immunoassay, the standard cutoffs for detection, and whether the assay is capable of detecting the parent drug, its metabolites, or both. Identify members of a drug class which are poorly or well detected by a generic immunoassay (e.g., oxycodone detection by the opiate immunoassay) and the common causes of false positives due to cross-reactivities.

8. PHARMACOGENOMICS

ADDITIONAL COMPETENCIES SPECIFIC TO CHEMISTRY

Patient Care "Chain of custody" and other legal requirements for forensic chemical

pathology.

Professionalism The social consequences of testing for drugs of abuse.

PAPER II

1. CARBOHYDRATE METABOLISM AND ITS DISORDERS.

Chemistry and Metabolism of carbohydrates:Clinical features and laboratory findings in insulin resistance, Type 1, Type 2 andgestational diabetes mellitus; diagnostic and monitoring criteria for diabetes; investigation of hypoglycemic syndromes (A).Glucose tolerance test procedures and interpretation (A); in pregnancy (A).Ketosis and lactic acidosis (A).Differential diagnosis of coma; hyperosmolar coma (A).Hemoglobin A1c (A); fructosamines (A); C-peptide (B).Insulin tolerance test (C); glucagon and somatostatin (C).Use and dangers of provocative tests, e.g. tolbutamide and glucagon (B).Assay of insulin, proinsulin and insulin antibodies (B).Albuminuria (A).Antibodies (anti-GAD, Anti-insulin, ect.).

2. PROTEINS, DISORDERS OF PROTEIN METABOLISM. Chemistry and Metabolism of Proteins and Ammaino acids.Clinical features and laboratory findings in disorders of the plasma proteins (A); acute phase proteins (A).Serum protein and albumin, serum and urine protein electrophoresis (A).Causes of hypoalbuminemia; hypo- and hyperglobulinemias (A).Alpha-1-antitrypsin deficiency (B).Ammaino aciduras, screening test for ammaino acid disorders.Methods for protein detection in body fluids.3. LIPID METABOLISM AND LIPOPROTEIN DISORDERS.

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Complete Chemistry and metabolism of lipidsClinical features and laboratory findings in disorders of triglycerides, lipoproteins and cholesterol metabolism (A).Lipid, lipoproteins and apolipoproteins metabolism; HDL, LDL, VLDL, apoA, apoB, apoC, apoE and their receptors (A).Fat absorption, transport, storage and metabolism (A).Investigation and principles of treatment of hyperlipidemias (A).Assessment of risk factors for atherosclerosis (A).Lipoprotein(a), lecithin:cholesterol acyltransferase (LCAT) (B).Lipid profile, Separation of lipoproteins

4. Chemistry and Metabolism of Nuclic AcidsNucleotides and their bases,DNA, RNA, Hiegh energy compounds.Major roles of purines and pyrimidines,synthesis of pyrimidines,pyrimidine salvage,catabolism of pyrimidines,synthesis of purines,purine salvage, catabolism of purines, GOUT.

5. VITAMINS Water soluble vitamins Fat soluble vitamins

6. ENERGY METABOLISM AND NUTRITIONFood calories, RQ, BMR, calorie requirements,proteins in nutrition, fats in nutrition,carbohydrates in nutrition, fibers in nutrition,protein –energy malnutrition,starvation,diet for normal adults, pregnant women,children, etc

7. MINERAL METABOLISM AND ITS DISORDERS.

Sodium and potassium,chlorine,calcium and phosphorus,magnesium,sulfur metabolism,Iron,copper,Zinc, Manganese, Molybdenum, Cobalt, Selenium, Iodine, Fluroine, chromium, Water Balance.

8. HORMONES AND ITS DISORDERS Horomone Families, Neurotransmitter families, Hormone receptors, Regulation of hormone secretion, Signal transductions, Gastrointestinal hormones, Hypothalamic hormones, Posterior pituitary hormony, anterior pituitary hormones, Melanocyte stimulating hormones, placental hormones, Calcitonin, parathyroid hormone, pancreatic hormones, diabetes mellitus, Insulin like growth factors, Adrenal medullary hormones, adrenal cortex hormones, Testosterone, Ovarian Hormones, Thyroid hormones, Regulation of blood sugar, Neurotransmitters.

9. RADIOISOTOPES, ITS APPLICATION AND ITS DETECTIONRadioactive emissions, Radiation – matter interaction, Radiation dose, Radiationmeasurement, Effects on human body, Radioisotopes in research, Radioisotopes in diagnosis, Radiotherapy

10. BIOLOGICAL OXIDATION AND ELECTRON TRANSPORT CHAIN (ETC.)

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Oxidoreductases, Redox potential, Mitochondrial respiratory chain, electron shuttles, oxidative Phosphorylation, Uncouplers of oxidative Phosphorylation.

11. FREE RADICALS AND ANTIOXIDANTS

M.Sc. MLT Biochemistry - IIGeneral Biochemistry Practicals:Buffers & Buffering capacity.Colorimetry.Spectrophotometry.Molar Extinction Co-efficient.Color reactions of Carbohydrates.Paper chromatography of Carbohydrates.Thin layer Chromatography of Carbohydrates.Color reaction of amino acids.Paper Chromatography of amino acids.Thin layer chromatography of amino acids.Ion exchange chromatography of amino acids.Serum ElectrophoresisEnzymesEffect of temperature on Enzyme activity.

Effect of substrate concentration on Enzyme activity. Effect of pH on the rate of reaction. Effect of enzyme concentration on the rate of reaction.

Clinical Biochemistry PracticalsAnti Coagulants.Blood Specimen Collection.Protein precipitants.Estimation of blood sugar by Folin wu method & Glucose Oxidase Method Estimation of blood urea by DAM method.Estimation of blood uricacid by Caraway’s method.Estimation of serum creatine & creatinine Jaffe’s method.Estimation of total serum protein by Biuret method.Estimation of Inorganic phosphorous by method of gomorri.Estimation of Cholesterol/HDL Cholesterol by enzymatic method. Estimation of Serum CalciumEstimation of Serum BilirubinEstimation of Alkaline & Acid PhosphataseEstimation of SGOT, SGPT, UV Kinetic Method and Gamma GTEstimation of LDHEstimation of Creatinine KinaseEstimation of Serum Amylase – Somogyi Amylolytic method

Estimation of Fe binding Capacity ( For Demonstration only ) Estimation of 17-Ketosteroids in urine ( For Demonstration only )

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Estimation of Serum C1, HCO3, pH, PO2, PCO2 blood gas analysis ( For Demonstration only ) CSF Analysis for Biochemical examination ( For Demonstration only ) Analysis of Urine for abnormal constituents Analysis of Body Fluids: Plural, Peritoneal, Ascitic and Pericardial ( For Demonstration only ) Estimation of Therapeutic drugs like Digoxin, phenotoin, carbamazapine, phenobarbitone, cyclosporine, Lithium ( For Demonstration only ) Estimation of Hormones - Thyroid hormones

SCHEME OF EXAMINATIONTheory: - There shall be two papers of 3 hrs duration, carrying 100 marks each.

M.Sc. MLT II Year – Paper I (Theory)

Biochemistry-II

THEORY EXAMINATIONDuration : 3 Hrs Max Marks:100Distribution of MarksSECTION – A Max Marks: 50SECTION – B Max Marks: 50 SECTION A – CLINICAL BIOCHEMISTRY

Type of questions No of questions for each subject

No. of questions and marks for each question

Total Marks

Long Essay 1 1x20 20

Short Essay 3 03x10 30

SECTION B – PHARMACOLOGICAL BIOCHEMISTRYType of questions No of questions for

each subjectNo. of questions and marks for each question

Total Marks

Long Essay 1 1x20 20

Short Essay 3 03x10 30

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M.Sc. MLT II Year – Paper II (Theory)

Biochemistry-II

THEORY EXAMINATIONDuration : 3 Hrs Max Marks:100Distribution of Marks

Type of questions No of questions for each subject

No. of questions and marks for each question

Total Marks

Long Essay 1 +1 2x20 40Short Essay 6 06x10 60

PRACTICAL EXAMINATION:

Day 11. Identification along with techniques in Chromatography or Electrophoresis – 30

2. Charts reporting - 10

3. Identification of abnormal constituents in any of biological fluids(urine / CSF / Ascetic fluid / Pleural fluid) any one - 15

Day 21. Estimation of Blood Sugar / Blood Urea / Uric Acid / Creatinine / Total Proteins / In organic Phosphorous / Cholesterol / Bilirubin - 20

2. Enzyme Kinetics (one of the factors effecting enzyme activity viz Temperature / pH / Substrate Concentration / enzyme concentration)

- 25

Total - 100

VIVA - 50Both internal and external examiners shall conduct the practical and viva- voce examination.

Grand Total -150

Reference Books:

Biochemistry – Strayer H.Gerjmetal-W.H.Freeman and company New York 5 th edition 2002.

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Lehnineger’s Principles of Biochemistry – Lehnineger. A.L., Nelson. D.L., Eral-C.B.S. Publishers and distributors, New Delhi 3rd edition.

Harper Illustrated Biochemistry – Murray R.K. Grannar, D.K. Mayes-P.A. Eral 26th edtion, McGrawHIll. 2003.

Medical Biochemistry – N.V. Bhagavan -Academic Press 4th edition 2002.

Text Book of Biochemistry – A.S. Saini, C.B.S Publishers and distributors 2nd edition.

Teitz fundamentals of Clinical Chemistry – Burtis. C.A. Ashoowd E. R. – Har Court (India) Ltd 5th edition 2001.

Varley’s Practical Clinical Biochemistry – Gowenlock and Bell William Heinemann, 6th edition 1992.

Text Book of Biochemistry with Clinical Correlations – Devlin T.M. Wiley Liss, New York 5th Edition 2002.

Clinical Physiology of Acid-Base balance and Electrolyte disorders – Rose. B.D – Mcgraw-Hill International edition New York 4th edition 1994.

Methods in Bio-Statistics for Medical students – Mahajan. B.K. Jaypee brothers Medical Publishers, New Delhi.

Manual of Practical Biochemistry for M.B.B.S –S.K.Gupta, Veena Singh Ghalaut- Arya publishing Company, New Delhi.

Clinical Chemistry – Theory analysis and Correlation – Kalpan. L.A. and pesse. A.G- C.V. Moslay and Company St. Louis, M.O. 2nd edition 1989.

Principles of Biochemistry – CBS Publishers – Lehninger, Nelson, Cox.

Journals for Reference: Clinica Chemica ActaJournal of Laboratory Clinical MedicineJournal of Clinical Investigation Biochemistry Journal Clinical Chemistry European Journal of Biochemistry.

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MICROBIOLOGY-II

PAPER-I: SYSTEMATIC BACTERIOLOGY, APPLIED MICROBIOLOGY AND IMMUNOLOGY

SYSTEMATIC BACTERIOLOGY 80 Hours

1. Normal flora of the human body.2. Collection transport, processing of specimens of diagnosis of

bacterial, viral and fungal infection in the following cases. Respiratory tract infections, gastrointestinal tract infections, genital tract infections, CNS infections wounds and abscesses, Eye, ear and sinus infections, infections of the blood, tissue samples for culture.Biological safety in clinical laboratory, quality control, modern techniques employed in clinical laboratory.

3. Nosocomial infections: Epidemiology, bacterial and viral infections, infections in paedriatic patients, surveillance and control programmes, organizations and associations involved, role of microbiology lab in prevention and control, devices associated intravascular infections and its control, device associated intravascular infections and its control, sterilization, disinfections and antisepsis in hospitals.

4. Respiratory tract infections: Upper respiratory tract: aetiology, transmission, pathogenesis, epidemiology and clinical features of following:

Common cold, Pharyngitis and Tonsillitis, otitis and sinusitis, acute epiglottitis, oral cavity infections, laryngitis, and tracheitis, diphtheria.

Lower respiratory tract- whooping cough, bronchitis, RSV infections, Bacterial diagnosis of respiratory tract infections.

5. Urinary tract infections and sexually transmitted diseases- Bacterial, viral and fungal infections of the urinary tract, etiology, pathogenesis, transmission, clinical features and diagnosis of syphilis, gonorrhoea, Chlamydial infections, HIV, bacterial, Vaginosis, genital herpes, papiloma virus infections, opportunistic STDs.

6. Gastrointestinal tract infections: etiology, pathogenesis, clinical features, and diagnosis of diarrhoel diseases (bacterial and viral),

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H.pylori, food poisoning, parasites in the GI tract, systemic infections from GI tract.

7. Central nervous system infections: meningitis caused bv bacteria, viruses, fungi and protozoa, viral encephalitis, brain abscesses, tetanus, botulism.

8. Infections of the skin, ear and eye: Etiology, transmission, diagnosis and prevention.

9. Microbiology of air, water and mild:common pathogens encountered, methods for microbiological analysis, methods for purification.

10. Identification of Non-fermenters- Pseudomonas, Acinetobacter, Stenotrophomonas

11. Commercial kit systems-API,Automated and semi-automated identification systems-BACTEC,Vitek

12. Quick screening methods, Chromogenic agar media

Bacteriology of Milk, Water and Air

Molecular biology techniques for characterization of microbes and viral agents. Bacteriological and viral serology.

4. Bacteriological and viral syndromes or diseases:epidemiology, main clinical signs, basis for biological diagnosis, treatment.

4.1 Meninged syndrome.4.2 Septicaemic syndrome.4.3 Urinary and genital infections.4.4 Bacteriological and viral diarrhoeas.4.5 Respiratory infections.4.6 Human acquired immunodeficiency syndrome.4.7 Sexually transmitted diseases.4.8 Hepatic virus infections.4.9 Cytomegalovirus infections

PRACTICALSStudy of normal flora of human body.

Isolation, characterization and identification of pathogens form various clinical

specimens.

Study of morphological, culture and biochemical characters of common bacterial

pathogens

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Study of antibiotic sensitivity of common pathogens.

Study of microbial flora of air in various localities.

Microbial analysis of water.

Microbial analysis of milk.

Procedure of skin clipping for Leprae bacilli.

Preservation of stock cultureBacteriology of food

PRACTICAL-Immunology1. Double diffusion technique2. Radial immuno diffusion 3. Haemagglutination inhibition test4. Haemagglutination test 5. Latex agglutination test 6. Complement fixation test7. Immunoelectrophoresis8. Countercurrent immunoelectrophoresis9. FITC conjugation of antibodies10. Lymphocyte culture 11. Isolation of lymphoid organs in mice12. RIA demonstration

APPLIED MICROBIOLOGY AND IMMUNOLOGY 60 Hours

1. History of immunology, innate and aquired immunity, meehanisms of innate immunity inflammation-inflammatory cells, mediators, inflammatory response types, antigens, cells and organs of immune system, evolution of immunity.

2. Immunoglobulin: Structure and function, classes and subclass-Cryoglobins, immunoglobulins genes –Organisation and expression, antibody diversity, class switching, monoclonal antibodies-hybridoma technique and MAB production, application in biomedical research, clinical diagnosis and treatment.

3. Immune Response: Clonal selection theory and related theories, primary and secondary response, humoral and cell mediated response, antigen processing and presentation, role of accessory molecules, MHC-structure and role in antigen presentation, MHC genes, maturation activation and differentiation of B cells and T cells, lymphocyte trafficking, TCR-structure anf generation of diversity, cytokine properties and function, cytokine receptor, therapeutic uses, ADCC, NK cell regulation of immune

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response, advances in the development of vaccines (eg. Haemophilus B conjugate, Pertusis, Cholera, Malaria, Hepatitis B, Polio, HIV, Antitumour) adjuvants.

4. Compliment system: function, compliment receptors, activation pathways, control mechanisms, role in inflammation, kinin cascade, kinnins in disease.

5. Immunity against bacteria: Virus, Fungi and Parasites.6. Immunological methods in clinical laboratories: Method interpretation and

application of the following.

a. Double diffusion in agarb. Single radial immuno diffusionc. Electrophoresis and immunoelectrophoresisd. Chromatographye. Ion exchange f. Affinity (gel)g. RIAh. Elisai. Western blottingj. Detection of immune complexes, nephelometryk. Immunoflouresencel. Agglutination test direct and indirectm. Haemagglutination and haemagglutination inhibitionn. Complement assays-CFTo. Hemolytic assaysp. Detection of cellular immunity-delayed hypersensitivity skin testq. Assays for lymphocytes-T and B cellsr. Flow cytometrys. FACSt. Mixed lymphocyte cultureu. NK cells neutrophil function testv. Histocompatibility testing

7. Auto Immunity8. Transplantation Immunity 9. Tumor Immunity

Text books for references:

1. Text book of Microbiology by Ananthnarayan, 6th Edition, Orient Longman 2. Diagnostic Microbiology by Bailey & Scott 11th Edition; Mosby

Medical Microbiology by Greenwood & Slack 16th Edition; Churchill Livinstone3. The Short Textbook of Medical Microbiology by Satish Gupte 8th Edition; Jaypee 4. Text book of Medical Parasitology by Panikar 5th Edition; Jaypee 5. Colour Atlas and Textbook of Diagnostic Microbiology by Koneman 5th Edition,

Williams Wilkins

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6. District Laboratory in Tropical Countries , Monica Cheesbrough 1st Edition, Cambridge

7. Mackie & Maccarteney Practical Medical Microbiology 14th Edition; Churchill Livingstone

8. Essential Immunology ,Roitts & Delves 10th Edition; Blackwel Science

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PAPER II - VIROLOGY, MYCOLOGY AND PARASITOLOGY 130 Hrs

- VIROLOGY ( 50 hrs)

1. Systematic study of the following viruses: their biological properties, pathogenecity, epidemiology; isolation and identification from clinical specimens, lab diagnosis, treatment and immunoprophylaxis against parvoviruses, Adenoviruses, Herpes viruses, pox viruses, Hepatitis viruses, picorna viruses, Rota viruses, orthomyxoviruses, paramyxoviruses, Rubella virus, pabies virus, papova virus, HIV, Oncogenic viruses.

- MYCOLOGY (20hrs)2. Systematic study of the following Fungi: Epidemiology,

pathogenesis, laboratory diagnosis, treatment and prophylaxis against superficial mycosis Ptyriasis versicolor, Tinea nigra, Tinea piedra, Dermatophytes, Subcutaneous mycosis Mycetoma, Sporotrichosis, chromoblastomycosis, Rinosporidiosis, Lobomyscosis, Systemic mycosis Histoplasmosis, blastomycosis, coccididiomycosis, paracoccididiomycosis, Oppurtunistic mycosis, crytococcosis, paracoccididiomycosis, Oppurtunistic mycosis- Crytococcosis, candidiasis, Aspergillosis, Zygomycosis, Keratomycosis and Otomycosis, Allergic fungal diseases, Mycotoxicosis.

-PARASITOLOGY (60hrs)

3. Study of morphology, important developmental stages, symptoms, pathogenesis, epidemiology, diagnosis, treatment, prevention of following parasites.

Entamoeba histolytica, Naeglaria, Giardia, Trichomonas, Balantidium, Isospora, Crytosporidium, Malarial parasites, Trypanosoma, Leishmania, Toxaplasma gondii, Pneumocystis carinii, TaeniaEchinococcus,Schistostoma, Paragonimius, Diphyllobothrium, Ascaris,Enterobius, Ancylostoma, Trichuris trichura, Wuchereria, Dracunculus,Trichinella spiralis.

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PRACTICALS

Common diagnostic tests used for detection of viral infections. Identification of fungal pathogens in clinical specimens. Diagnostic tests for detection of parasitic infections- methods for

demonstration of parasites in clinical specimens preparation of blood smear for detection of filarial parasites.

.ELISA test HIV & HBsAg

Scheme of ExaminationM.Sc. MLT II Year – Paper I (Theory)

SYSTEMATIC BACTERIOLOGY APPLIED MICROBIOLOGY AND IMMUNOLOGY

THEORY EXAMINATIONDuration : 3 Hrs Max Marks:100Distribution of Marks

Type of questions No of questions for each subject

No. of questions and marks for each question

Total Marks

Long Essay 1 (SB), 1(IM) 2x20 40Short Essay 3 (SB), 1 (IM),

2 (AM ) 06x10 60

SB: Systematic Bacteriology. IM: Immunology. AM: Applied Microbiology

Subject wise distribution as follows:Systematic Bacteriology – 50Applied Microbiology - 20Immunology -30

Total- 100

MSc MLT II year- Paper II (Theory)

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VIROLOGY, MYCOLOGY AND PARASITOLOGY

THEORY EXAMINATION

DURATION:3 hrs Max Marks: 100DISTRIBUTION OF MARKS

Type of questions

No of questions in each subject

No. of questions and marks for each question

Total

Long Essay 1( P),1(V) 2x20 40Short Essay 3(P), 1 (V),

2 (M)06x10 60

P- Parasitology V-Virology M-Mycology

Subject wise distribution as follows:Parasitology - 50Virology – 30Mycology - 20Total – 100

MSc. MLT II year – Microbiology II (PRACTICAL EXAMINATION)

DURATION :3 days Max Marks:100

Exercise Marks

Day 11. Liquid Culture / Mixed Culture for identification only 252. A specimen with a case history to be given for identification and if necessary antibiotic sensitivity should also be done (Bacterial / Fungal) 253. Media Preparation 104. Virology – HIV / HBsAg by ELISA method (3rd or 4th generation ELISA assays only applicable and not rapid tests) 10

Day 21. Continuation of Liquid Culture / Mixed Culture for identification 2. Continuation of the specimen with a case history to be given for identification and if necessary antibiotic sensitivity (Bacterial / Fungal)3. Stool concentration method 10

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4. Mycology identification of dermatophyte /yeast culture 105. Serology Exercise 10

Day 31. Continuation of Liquid Culture / Mixed Culture for identification 2. Continuation of the specimen with a case history to be given for identification and if necessary antibiotic sensitivity (Bacterial / Fungal)Total 100

VIVA 50

Grand Total 150

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Haematology & Blood Transfusion-II

Paper I – HeamatologyTHEORY1. General aspects: Blood cell formation,Sites of haemopoiesis. Development of blood cells.

Morphology and Regulation of heaemopoiesis.

2. Red cells – Basic aspects of anaemia definition, patho physiology ,classification and clinical

features. Investigation of a case of anaemia in general.

3. Microcytic hypochromic anaemias

Sideroblastic anemia

Anaemia of chronic infection

Thalassaemia.

Iron deiciency anaemia – Iron metabolism ,causes of iron deficiency, clinical features,

laboratory investigations.

4. Macrocytic Anaemias

Megaloblastic

Non megaloblastic

Megaloblastic anaemia – Etiology, clinical features, laboratory investigation. Pernicious

anaemia.

5. Normocytic normochronic anaemia

Anaemia in systemic disorders

Acute blood loss, Renal failure

Liver disorders etc.

6. Disorders of Haemoglobin

Structure of Hb and Synthesis

Normal and Abnormal haemoglobins

Hamoglobinspathies

7. Haemolytic anaemia

Definition, pathogenesis, classification, clinical features, Extrinsic factors & Intrinsic factors -

investigation

Laboratory investigations to establish a case of haemolytic anaemia.

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1. Peripheral smear – spceific morphologic abnormalities

2.Special tests

a) Osmotic fragility test

b) Sickling test

c) Kleihaure acid elution test

d) Alkali denaturation test

e) Ham’s test ,

f) Sucrose lysis test

g) Coomb’s test

h) Electrophoresis – HbF, HbA2 estimation

i) Tests for G6PD deficeiency

3. Hemolytic disease of new born – causes and investigations

8. Aplastic anaemia

Pancytopenia.

9. Polycythaemia – classification Clinical features, laboratory investigation

II Leucocyte disorders

Leukaemoid reaction – type of leukaemoid and diagnosis.

Myelodysplastic syndrome [ MDS ] Definition, clinical features, peripheral

smear and Bone marrow findings.

Leukaemias: Definition, –French- American-British [FAB ] and

World Health Organization- classification of acute leukaemias

Diagnostic criteria , Cytochemical staining and Immunophenotyping

Chronic Leukaemias: classification, Diagnostic criteria .

Myeloproliferative disorders – classification ,Clinical features, laboratory investigations.

Chronic myeloid leukaemia in detail.

Lymphoproliferative disorders.- Chronic lymphocytic leukaemia in detail.

Plasma cell disorders – classification.

Plasma cell myeloma – definition. Clinical features, laboratory investigations.

Haemorrhagic disorders:

Definition: Pathogenesis, clinical features,

Classification: a. Primary hemostasis, b. secondary hemostasis – causes and investigations of

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both.

Fibrinolysis.

Platelet disorders:

Quantitative – Thrombocytopenia - Idiopathic thromobcytopenic purpura ( ITP )

Classification, clinical featrues, diagnosis and bone marrow findings in ITP.

Qualitative platelet disorders.

Thromobcytosis – Definition ,Etiology,. Lab Investigations

Coagulation disorders – Inherited -Haemophilia A and B, von Willebrand’s disease,

Acquired: Vit. K deficiency, Liver disease, DIC

Investigation of Haemorrhagic disorders.

Tests of vascular and platelet function - Bleeding time, Clot retraction ,Patelet count.

Platelet aggregation studies. Bone marrow examination.

Tests for coagulation disorders: Screening tests- First line tests -Prothrombin time (PT),

Activated partial thromboplastin time(APTT) Thrombin time (TT)

Second line tests – Mixing experiments.

Coagulation factory assay.

Urea solubility tests for Factor XIII.

Factor VIII inhibitor study.

Fibrinogen assay.

Disseminated intravascular coagulation- Definition, Pathogenesis, laboratory investigations

Thrombotic disorders:

Classification - Inherited and Acquired.

Clinical features, Investigation of thrombotic disorders:

Tests: i. Protein C

ii Protein S,

iii. AT-III

iv Factor V leiden

Antiphospholipid antibody syndrome: Defintion clinical feature laboratory investigation.

B.M.Examination- Aspiration and Trephin biopsy staining

Automation in haematology

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Molecular genetics in hematology

Cleaning of glass ware

Organization and quality control in the laboratory

Bio medical waste management .

Practicals 1. Staining and Interpretation of Peripheral smears.

2. Microcytic hypochromic anaemia- Peripheral smear, bone marrow Examination , Serum

iron. Serum Total iron bindng capacity [TIBC ] Percentsaturation, Serumferritin,

1 bone marrow. Ironstain .

3.Macrocytic Anaemia- Peripheral smear, bone marrow. Examination, Vit B12 assay,

Folate assay,Schilling Test.

4. Plasma Hb Estimation

5. Haemolytic Work up

Peripheral smear – spceific morphologic abnormalities

Special tests

j) Osmotic fragility test

k) Sickling test

l) Kleihauer acid elution test

m) Alkali denaturation test

n) Ham’s test, Sucrose lysis test

o) Coomb’s test

p) Electrophoresis – HbF, HbA2 estimation

q) Tests for G-6PD deficiency

6. Leukaemias: i. Myeloperoxidase

ii. Periodic Acid Phosphatase [PAS]

iii. Sudan Black

iv. Esterase, Non specific esterse

v. Leucocyte alkaline Phsophatase

Immuno Cytochemical Staining.

1. Plasma cell Disorders : Serum Protein Electrophoresis

Urine Electrophoresis

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2. Investigation of Haemorrhagic disorders

Test of vascular and platelet function – Bleeding time, Clot retraction, Platelet count.

Platelet aggregation studies. Bone marrow examination.

Tests for coagulation disordrs:

Screening tests – First line tests- Prothrombin time (PT), Activated partial thromboplastin

time(APTT), Thrombin time(TT), INR.

Second line tests – Mixing experiments.

Coagulation factor assay

Urea solubility tests for Factor XIII

Factor VIII inhibitor study

Fibrinogen assay

3. Thrombotic Work-up

Tests: i. Protein C

ii. Protein S

iii. AT-III

iv. Factor V leiden

4. Antiphospholipid Antibody –work up

5. Bone marrow examination – Preparation of B.M Aspiration and Trephine biopsy smears

staining

6. Organisation and quality control in the laboratory

7. Cleaning of glass ware

8. Bio Medical waste management

9. Preparation of Reagents, Diluting fluids,

Stains – Leishman’s stain

Geimsa stain

M.G.G stain

Recommended Books –Haematology and Clinical Pathology

1. Clinical Haematology

Illustrted – Colour Atls

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Victor Hoffbrand, John E Peth’t

2. Practical Haematolgoy – 9th edition Dacie 7 Lewis

3. Haematology –6th edition – Williams

4. Wintrobe clinical haematology Vol- I - 10th edition

5. Wintrobe clinical haematology Vol- II -10th edition

6. Lynch’s Medical Lab – Technology Latest edition

7. Clinical Diagnosis & Management – Todd & Sanford 19th edition 1996

8. Medical Laboratory Technology by Sood 5th edition, Jaypee Brothers 1999

9. Clinical Haematology in Medical Practice – G.C. Degruchy – 5th edition

Paper II – Blood Transfusion

TheoryIntroduction to Immuno Haematology

1. History of Transfusion Medicine

2. Blood groups and genetics

ABO System – ABO sub groups

Bombay group, secretors , non secretors. Rh system – Importance of Rh system

Du red cells (A variant of Rh system)

MNS System – clinical significance

3. Blood transfusion – indications for blood transfusion

4. Blood donation , Donor registration, Donor selection, Blood collection. Adverse donor reaction

5. Anticoagulants used to store blood

Changes occuring in the stored blood

6. Blood group systems – antigen – antibody reaction ,ABO system- Forward grouping

reverse group

7. Rh system Inheritence& nomenclature R h grouping – Rh antigen and antibodies DuVariant

Anti D type of reagents and their application

8. Coomb’s test – Application – DCT, ICT Rh antibody titre

9. Compatibility testing – Major

Minor

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Coomb’s cross match

10. Blood components – Indications preparation of blood components

11 Autologous transfusion

12. Transfusion transmitted disease

13. Haemolytic disease of the new born and exchange transfusion

14.Transfusion Therapy

15. Transfusion in Special Situations-Auto immune haemolytic anaemia

16.Transfusion reactions and investigation of transfusion reaction

17.Transfusion transmitted infections

18. Immunomodulation and graft versus host reactions .

19. Haemapheresis-Definition ,Types of pheresis ,Machines and Techniques.

20. Tissue banking

21.Cord blood banking

22. Stem cell processing, storage and transplantation

23..Disposal of wastes and biologically hazardous substance in the blood bank

24.Medico legal aspects of blood transfusion

25.Technical advances and future trends in blood banking

26.Paternity testing

27.Orientation of a routine blood bank

28.Quality Assurance - General condition

Equipment

Reagents

Donor processing

29.Drugs control regulation and Blood Bank

Practicals

Blood grouping – ABo grouping, Forward grouping (slide & tube method)

Reverse grouping – preparation of pooled A, B & O cells

Grading of Reaction. Other methods of grouping.

AB0 antibody titration, Cold antibody titration.

Rh grouping & Rh typing (slide & tube method)

6

Du Testing

Rh – antibody titration

Antiglobulin Testing

Direct and Indirect

Preparation of Coomb’s Control Cells.

Compatibility Testing

Selection of blood

Crossmatching Technique – Major, Minor, Saline, Albumin, Coomb’s

Emergency –Cross matches

Blood Collection

Donor selection

Blood collection [Phlebotomy]

Post donation Care

Preservation and Storage of blood

Preparation and Storage of blood Components

Packed Cells ,Fresh Frozen plasma [FFP], Platelet Concentrate, Cryoprecipitate

Component transfusion – selection of blood group

Crossmatching in Special Situations

Exchange transfusion – selection of blood group

Autoimmune haemolytic anaemia

Investigation of Blood Transfusion reaction

Testing for transfusion Transmitted Diseases

Elisa-HIV,HBsAg ,HCV

VDRL Test

Malaria

Quality control – Methods

Reagents

Test methods

Products

Documents

Equipment

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Apheresis procedures - Types of pheresis, Machines and Techniques.

Biomedical Waste mangement - Demonstration

Record keeping – To be observed

Documentation

Books Recommend for Blood Transfusion

1. Technical manual – 12th edition – AABB

2. The Clinical use of Blood Handbook, WHO

3. ABO Rh system – Ortho diagnostics

4. Compatibility testing – Ortho diagnostics

5. Compendium of transfusion medicine, Fr. R. N. Makroo. Ed. 1999

6. Bl ood transfusion in Clinical Medicine - Mollision – 5th edition

7. Blood group Serology, Theory, Techniques, Practical application – K.E.Boorman ,

B.E Dodd, P.J. Lincoln – 5th edition

8.Technical Manual, 12th edition, AABB.

9. Rossi’s Principles of Transfusion Medicine,

Toby L.Simon ,Walter H Dzik,Edward L. Snuder , Christopher P.Stowell

Ronald G.Strauss, 3 rd edition, Lippincott, 2002.

Scheme of ExaminationTheory: - There shall be two papers of 3 hrs duration, carrying 100 marks each.

Paper I – Heamatology Paper II – Blood Transfusion

M.Sc. MLT II Year – Paper I (Theory)

Heamatology

THEORY EXAMINATIONDuration : 3 Hrs Max Marks:100Distribution of Marks

Type of questions No of questions for each subject

No. of questions and marks for each question

Total Marks

Long Essay 2 2x20 40Short Essay 6 06x10 60

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M.Sc. MLT II Year – Paper II (Theory)

Blood Transfusion

THEORY EXAMINATIONDuration : 3 Hrs Max Marks:100Distribution of Marks

Type of questions No of questions for each subject

No. of questions and marks for each question

Total Marks

Long Essay 2 2x20 40Short Essay 6 06x10 60

Practical Examination - Total –100 marks

Day 1 Hematology1. Spotters (including slides, instruments) - 20 marks2. Case study of Patient – Drawing blood, preparing film and interpretation of peripheral smear - 20 marks3. Hemolytic Anemia workup or Screening of Hemorrhagic disorders test ( PTT, APTT, TT) - 10 marks

Day 2Blood Transfusion1. Blood grouping / typing -10 marksor Rh Typing & Dn testing2. Coomb’s - 10 Marks3. Cross Matching (Any two) - 10 Marks Major, Minor, Saline, Albumin and Coomb’s4. Charts for interpretation –Haematology - 5 marks5. Demonstration of Blood collection and selection of donor - 10 marks6. Charts for interpretation - 5 marks

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C. Viva Voce - The Viva Voce exam will carry 50 marks and all the examiners will conduct the Examination.Distribution of marks

1. Haematology – 25 marks2. Blood Transfusion – 25 mark

7

SECTION-IVMONITORING LEARNING PROGRESS

It is essential to monitor the learning progress of each candidate through continuous appraisal and regular assessment. It not only also helps teachers to evaluate students, but also students to evaluate themselves. The monitoring be done by the staff of the department based on participation of students in various teaching / learning activities. It may be structured and assessment be done using checklists that assess various aspects. Model Checklists are given in this Chapter which may be copied and used.

The learning out comes to be assessed should include:

i) Acquisition of Knowledge : The methods used comprise of `Log Book’ which records participation in various teaching / learning activities by the students. The number of activities attended and the number in which presentations are made are to be recorded. The log book should periodically be validated by the supervisors. Some of the activities are listed. The list is not complete. Institutions may include additional activities, if so, desired.

Journal Review Meeting (Journal Club): The ability to do literature search, in depth study, presentation skills, and use of audio- visual aids are to be assessed. The assessment is made by faculty members and peers attending the meeting using a checklist (see Model Checklist – I, Section IV)

Seminars / Symposia: The topics should be assigned to the student well in advance to facilitate in depth study. The ability to do literature search, in depth study, presentation skills and use of audio- visual aids are to be assessed using a checklist (see Model Checklist-II, Section IV)

ii) Teaching skills : Candidates should be encouraged to teach undergraduate medical students and paramedical students, if any. This performance should be based on assessment by the faculty members of the department and from feedback from the undergraduate students (See Model checklist III, Section IV)

iii) Dissertation: Please see checklist IV and V in Section IV.

iv) Work diary / Log Book- Every candidate shall maintain a work diary and record his/her participation in the training programmes conducted by the department such as journal reviews, seminars, etc. Special mention may be made of the presentations by the candidate as well as details of experiments or laboratory procedures, if any conducted by the candidate.

v) Records: Records, log books and marks obtained in tests will be maintained by the Head of the Department and will be made available to the University.

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Log book

The log book is a record of the important activities of the candidates during his training, Internal assessment should be based on the evaluation of the log book. Collectively, log books are a tool for the evaluation of the training programme of the institution by external agencies. The record includes academic activities as well as the presentations and procedures carried out by the candidate.

Format for the log book for the different activities is given in Tables 1 and 2 of Section IV. Copies may be made and used by the institutions.

Procedure for defaulters: Every department should have a committee to review such situations. The defaulting candidate is counseled by the guide and head of the department. In extreme cases of default the departmental committee may recommend that defaulting candidate be withheld from appearing the examination, if she/he fails to fulfill the requirements in spite of being given adequate chances to set himself or herself right.

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Format of Model Checklists

Checklist-I : MODEL CHECKLIST FOR EVALUATION OF JOURNAL REVIEW PRESENTATIONS

Name of the student: Date:

Name of the faculty/ Observer:

Sl No. Items for observation during presentation

Poor0

Below average1

Average2

Good3

Very Good4

1 Article chosen was 2 Extent of

understanding of scope & objectives of the paper by the candidate

3 Whether cross- references have been consulted

4 Whether other relevant references have been consulted

5 Ability to respond to questions on the paper /subject

6 Audio-visuals aids used

7 Ability to defend the paper

8 Clarity of presentation

9 Any other observationTotal score

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Checklist-II :MODEL CHECK LIST FOR THE EVALUATION OF THE SEMINAR PRESENTATIONS

Name of the student: Date:

Name of the faculty/ Observer:

Sl No. Items for observation during presentation

Poor0

Below average1

Average2

Good3

Very Good4

1 Article chosen was 2 Extent of

understanding of scope & objectives of the paper by the candidate

3 Whether cross- references have been consulted

4 Whether other relevant references have been consulted

5 Ability to respond to questions on the paper /subject

6 Audio-visuals aids used

7 Ability to defend the paper

8 Clarity of presentation

9 Any other observationTotal score

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Checklist - III : MODEL CHECK LIST FOR EVALUATION OF TEACHING SKILL

Name of the student: Date:

Name of the faculty/ Observer:

SL. No.

Strong Point Weak point

1 Communication of the purpose of the talk2 Evokes audience interest in the subject3 The introduction 4 The sequence of ideas5 The use of practical examples and /or

illustrations6 Speaking style (enjoyable, monotonous,

etc., specify)7 Summary of the main points at the end 8 Ask questions9 Answer questions asked by the audience10 Rapport of speaker with his audience11 Effectiveness of the talk12 Uses of AV aids appropriately

Checklist - IV : MODEL CHECK LIST FOR DISSERTATION / PROJECT WORK PRESENTATIONS

Name of the student: Date:

Name of the faculty/ Observer:

Sl No.

Points to be considered

Poor0

Below average1

Average2

Good3

Very Good4

1 Interest shown in selecting topic

2 Appropriate review3 Discussion with guide

and other faculty4 Quality of protocol5 Preparation of

proformaTotal score

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Checklist - V : CONTINUOUS EVALUATION OF DISSERTATION / PROJECT WORK BY GUIDE/ CO-GUIDE

Name of the student: Date:

Name of the faculty/ Observer:

Sl No. Items for observation

during presentation

Poor0

Below average1

Average2

Good3

Very Good4

1 Periodic consultation with guide/ co-guide

2 Depth of Analysis/ Discussion

3 Department presentation of findings

4 Quality of final output

5 OthersTotal score

OVERALL ASSESSMENT SHEET

Date:

Check list No. Name of the studentsA B C D

123

Signature of the HOD Signature of the Principal

The above overall assessment sheet used along with logbook should form the basis for certifying satisfactory completion of course of study, in addition to the attendance requirement.

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KEYMean score: Is the sum all the scores of checklists 1 to 5A, B, C : Name of the students

LOG BOOK

Table 1 : Academic activities attendedName :Admission Year:College:

Date Type of activity, Specific Seminar, Journal club, presentation, UG teaching

Particulars

LOG BOOK

Table 2 : Academic presentations made by the studentName :Admission Year:College:

Date Topic Type of activity, Specific Seminar, Journal club, presentation, UG teaching

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MANAGEMENT INFORMATION SYSTEM REPORT

1. Name of the college imparting M.Sc. MLT PG Program: 2. Details of M.Sc. MLT Program

Sl.No

Name of the Branch & Teaching faculty

Sanctioned Strength

Admitted Name of the subjects to be studied at 1st Year M.Sc. MLT

1

2

3. No. of experiments/assignments conducted for 1st year M.Sc. MLT students

Sl.No

Branch Subject Assigned by

RGUHS

Conducted

% Remarks

1. No Name

2

4. No. of theory classes conducted for 1st year M.Sc. MLT students

Sl.No

Branch Subject RGUHSNorms

(25)

Conducted

% Remarks

1. No Name

2.

3.

5. Number of theory and practical classes taken by 2nd year M.Sc. MLT students for under graduate Program (Optional)

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6. No. of Journal clubs department wise for 1st year and 2nd year M.Sc. MLT students

Total No. of students Dept Wise

Norms for half yearly Report

Achieved Number

% Achievement Remarks

1st year M.Sc. MLTNo.=

2 per candidate per year

2nd year M.Sc. MLT No.=

2 per candidate per year

7. Number of seminars for 1st year and 2nd year M.Sc. MLT students

Total No. of students : 10

Norms for half yearly Report

Achieved Number

% Achievement Remarks

1st year M.Sc. MLTNo.=10

2 per candidate

2nd year M.Sc. MLT No.= 08

2 per candidate

8. Number of interdepartmental meetings

Norms for half yearly Report

Achieved Number

% Achievement

Remarks

1 2 200% Interactive and productive

9. Number of visits to pharmaceutical industry/research center/hospital for 1st year and 2nd

year M.Sc. MLT students

Norms for half yearly Report

Achieved Number

% Achievement

Remarks

1 02 200 Educative & informative

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10. Number of guest lectures for postgraduate Program

Norms for half yearly Report

Achieved Number

% Achievement

Remarks

2 03 150 Need focused and educative

11. Number of research papers published in the year in the college –

12. Any other additional information such as consultancy/collaboration/conducting Seminars & workshops or attending seminar & workshops or conference.

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SECTION-VETHICS IN M.Sc. MLT

(Should be taught to the Ist year students of M.Sc. MLT of three branches of specialization.)

Introduction: With the advances in science and technology and the increasing needs of the patient, theirs families and community, there is a concern for the health of the community as a whole. There is a shift to greater accountability to the society. It is therefore absolutely necessary for each and every one involved in the health care delivery to prepare themselves to deal with these problems. Technicians like the other professionals are confronted with many ethical problems.

Standards of professional conduct for technicians are necessary in the public interest to ensure an efficient laboratory service. Every technician should not only be willingly to play his part in giving such a service, but should also avoid any act or omission which would prejudice the giving of the services or impair confidence, in respect, for technician as a body.

To accomplish this and develop human values, it is desired that all the students under go ethical sensitization by lectures or discussion on ethical issues.

Introduction to ethics-What is ethics?General introduction to Code of Laboratory EthicsHow to form a value system in one’s personal and professional life?International code of ethics.

Ethics of the individual-Technician relation to his jobTechnician in relation to his tradeTechnician in relation to medical professionTechnician in relation to his profession

Professional Ethics-Code of conductConfidentialityFair trade practiceHandling of prescriptionMal practice and NegligenceProfessional vigilance

Research Ethics-Animal and experimental research/ humannessHuman experimentation

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Human volunteer research - informed consent Clinical trialsGathering all scientific factorsGathering all value factorsIdentifying areas of value – conflict, setting prioritiesWorking out criteria towards decisionICMR/ CPCSEA/ INSA Guidelines for human / animal experimentation

Recommended reading

Francis C.M., Medical Ethics, I Edition, 1993, Jay pee Brothers, New Delhi p189.Good Clinical Practices : GOI Guidelines for clinical trials on Pharmaceutical Products in India (www.cdsco.nic.in)INSA Guidelines for care and use of Animals in Research – 2000.CPCSEA Guidelines 2001(www.cpcsea.org).Ethical Guidelines for Biomedical Research on Human Subjects, 2000, ICMR, New Delhi.ICMR Guidelines on animal use 2001, ICMR, New Delhi.

8

SECTION VI

MINIMUM REQUIREMENT OF INFRASTRUCTURE, LABORATORY FACILITIES AND STAFF FOR M.Sc.MLT COURSE

FOR ALL THE THREE BRANCHES. I. Basic Infrastructure applicable to all three branches: Institute should have its own Hospital with full fledged Clinical Laboratory or its own diagnostic centre or own independent Clinical laboratory provided the above mentioned facilities fulfill the minimum work load criteria for each of the subject branch mentioned here under.Basic Laboratories: -1. Three labs with area of 800sq.ft each 2. One lab for Immunopathology 10x10 sqft Electricity with back -up3. One class room with capacity for 30 students measuring 500sq.ft. 4. One departmental Seminar room measuring 250sq.ft for each branch with A.V aids – OHP,Slide projector and computer with accessories are compulsory. LCD Projector (optional) Other infrastructure criteria- Principals room, students common room, staffroom, Library, office room, Store room, preparation room etc will be as per minimum criteria. Norms of B.Sc MLT course.

II. Infrastructure subject wise:

A. Clinical Biochemistry a. Laboratory equipments

1. Chemical Balance/single Pan Balance2. Colorimeter3. Spectro Photometer4. Flame Photometer/ ISE Electrolyte analyzer5. pH meter6. Chromatography instruments7. Electrophoresis unitG

8

8. Semi auto analyser9. Auto analyser10. Electro Chemiluminescence / Drug and Harmone analyser (optional) 11. Blood gas analyser12. Refrigerator

Apart from the above mentioned equipments ,necessary glass ware, kits, chemicals, as per the syllabus requirements should be made available in adequate quantity.

b. Minimum work load criteria for conducting M.Sc MLT.in Clinical Biochemistry. 100 different bio-chemical tests per day [Routine and special tests]

B. Microbiology and Immunology a. Laboratory equipments

1. Auto clave -22. Hot air oven -23. Incubator -24. Centrifuge -25. Water distillation/Purification unit -16. Phmeter -17. B.O.D. Incubator -18. Physical Balance -19. Digital Balance -110. Refrigerator -311. Microscope - Monocular 10

- Binocular – 5 - Dark field Microscope – 1- Fluorescent microscope – 1

12. ELISA reader -113. Electrophoresis unit -114. Anaerobic Jar -215. Micropipettes -416. Pressure cooker 117. Laminar air flow -118. Water bath -219. VDRL shaker -2

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20. Deep freezer -1Apart from the above mentioned equipments necessary glassware, kits, chemicals as per the syllabus requirements should be made available in adequate quantity

b. Minimum work load criteria for conducting M.Sc MLT course in Microbiology and Immunology

100 different types of samples per day including serological testsi Serological tests - 50/dayii Cultures - 20/day.

C. HAEMOTOLOGY a. Laboratory equipments

1. Blood cell counter - 1

2. Coaggulometer 1

3. Spectrophotometer 1

4. Refrigerator – 165 lit 2

5. Hot air oven 2

6. Electronic Balance (Libror) 1

7. Water bath 1

8 Distilled water unit 1

9. Centrifuges 2

10. QBC RM12C 1

11. Becton Dickinson Illuminator 1

12. Centrifuge – Vanguard V6500 1

6cups [Roche Biomedical Lab]

13. Centrifuge – Lab Corp. of America 1

6cups [110v supply]

14. Hb Electrophoresis Machine 1

(Tank, Scanner, monitor Printer, CPU)

15. ELISA reader 1

16. pH meter 1

17. Autoclave 1

18. Microscope – Binocular 10 [One for each

8

Student ]

19. Haemocytometer One per student 20. Westergren pipette One per student 21. D C counter One per student22. Calorimeter 1 23. Urinometer 1 24. Albuminometer 1

Apart from the above mentioned equipments necessary glassware, chemicals,kits, should be made available in adequate quantity.

b. Minimum work load criteria for conducting M.Sc MLT course- Haematology 100 samples per day Haematology Including Clinical Pathology samples

Haematology samples should include following Special type of investigations

1. Haemolytic work up

2. Coagulation work up

3. Thrombotic work up

4. Bone marrow Aspiration and Trephine biopsy.

BLOOD TRANSFUSION

College/Institute should have its own Licensed Blood Bank and should be as per the guide

lines laid down by the drug controller.

BLOOD BANK

a.Laboratory equipments

1. Blood Bank Refrigerator 2

2. Domestic Refrigerator 1

3. Centrifuge – 16 tube capacity 1

8 tube capacity 1

4.Water bath 1

5.Thawing bath 1

6 Microscope 1

7. Photoelectric Colorimeter 1

8. view box 1

8

9. Weighing Machine 1

10. Hot air Oven 1

11.Elisa Reader with washer 1

12. VDRL Rotator 1

13 .Donor cots with mattress and pillows 2 (ICU cots)

14. Blood collection Monitor 1

15 .Spring Balance 2

16..Deep Freezer - 300C Horizontal 1

17. Deep Freezer - 700C Horizontal / Vertical 1

18. Platelet Agitator with Incubator 1

19. Refrigerated Centrifuge 1

20. Laminar Flow 1

21.Tube sealer 2

22.Cobe Spectra Cell Seperator 1

23. Couch 1 Optional

24. Automatic component extractor 1

25. Component weighing scale 1

26. Rough Balance 1

27. Oxygen cylinder 1

b. Minimum work load criteria for conducting M.Sc MLT course in Blood Transfusion

10 -Transfusion per day

30 blood samples/day for- i grouping & typing

ii crossmatching

iii Special Tests – Coomb’s Test [Direct &Indirect ]

ABO antibodyTitre , Cold antibody Titre.etc

Component preparation unit (optional) - However Students should be posted for 1month

to a Blood bank where Component preparation facility is available.

Apart from the above mentioned equipments necessary glassware, chemicals, kits, should be

made available in adequate quantity.

9

D. IMMUNOPATHOLOGYa. Laboratory equipments

1. Refrigerator2. Micro oven3. Microtome4. Hot air oven5. Water bath6. Coil stove7. Cooker – 7.5 ltr8. Physical balance 9. Binocular Bright field Microscope.10. Cryostat (optional) in case immunoflurosecsence is required.

Teaching staff requirements applicable for all the branches of M.Sc. MLT:Teaching staff should actively involve in teaching the particular subject.1. Professor - 1 2. Associate Professor - 1 - 5yrs teaching experience3. Assistant Professor - 1 - 3yrs teaching experience4. Lecturer - 2 (M.Sc.MLT with one year of teaching experience)5. Tutors – 2 MBBS, M.Sc.(Medical),M.Sc. MLTQualification : 1. MD in respective subject.2.M.Sc –[only Medical Microbiology/Medical Biochemistry degree acceptable)

3 yrs experience after M.Sc.4.Bio-technologist – M.Sc in Biotechnology

Non-Teaching staff - Bio-technologist – M.Sc in Biotechnology Senior technician - 1 Junior technician - 2 Peon - 1

9

ANNEXURE – I(See Rule 5)CATEGORIES OF BIO-MEDICAL WASTE

** Waste Category No Waste Category ** Type Treatment a Disposal ** Options

Category No. 1 Human Anatomical Waste:(human tissues, organs, body parts)

Incineration deep burial

Category No. 2 Animal Waste: (animal tissues, organs, body parts, carcasses, blooding parts, fluid, blood and experimental animals used in research, waste generated by veterinary hospitals colleges, discharge form hospitals, animal houses)

Incineration deep burial

Category No. 3 Microbiology & Biotechnology Waste: (wastes from laboratory cultures, stocks or specimens or micro-organisms live or attenuated vaccines, human and animal Cell culture used in research and infectious agents from research and industrial laboratories, wastes from production of biologicals, toxins, dishes and devices used for transfer of cultures)

Local autoclaving / micro waving / incineration.

Category No. 4 Waste sharps:(needles, syringes, scalpels, blades, glass, etc, that may cause puncture and cuts. This includes both used and unused sharps)

Disinfection (chemical treatment / autoclaving / micro –waving and mutilation / shredding

Category No. 5 Discarded Medicines and Cytotoxic drugs:(wastes comprising of outdated, contaminated and discarded medicines)

Incineration / destruction and drugs disposal in secured landfills.

Category No. 6 ** Solid Waste: (items contaminated with blood, and body fluids including cotton, dressings, soiled plaster casts, Eners, beddings, other material

Incineration Autoclaving / micro waving

9

contaminated with blood) Category No. 7 Solid Waste:

(wastes generated form disposable items other than the waste ** sharps such as tubing’s, catheters, intravenous sets, etc)

Disinfection by chemical treatment, autoclaving / micro-waving and mutilation / shredding

Category No. 8 Liquid Waste:(waste generated from laboratory and washing, cleaning, housekeeping and disinfecting activities)

Disinfection by chemical treatment and discharge into drains

Category No. 9 Incineration Ash:(ash from incineration of any biomedical waste)

Disposal in municipal landfill

** As per Bio-Medical Waste (Management & Handling) ( Second Amendment) Rules 200, dated 02.06.2000.

9