A-2B/155A, EKTA APARTMENT, NEAR DIVINE HAPPY SCHOOL, PASCHIM VIHAR, NEW DELHI-110063drjain12@yahoo.com www.melap.in

+91-9810492621, 9313679026

MELAP

(Concept & Application)QUALITY IN CLINICAL LAB

3 Days (2+1)Training ProgrammeTraining ProgrammeTraining Programme

Timings: 9.00 am - 4.00 pm

Registration Fee:

Who Should Attend?• Pathologist• Microbiologist• Biochemist• Quality Manager• Lab Technician

Programme Type

2 Day

1 Day

2+1 Day

For Doctor's

4000/-

2000/-

5000/-

For Technical Staff

3000/-

1500/-

4000/-

2

Dr. Neeraj JainMBBS, MD., (Path)

President & Course Director - MELAP

Two Days

3

27. Reporting the results

28. Release of examination results

29. Confidentiality of patient’s information

C. Standard Operating Procedures (SOP)

1. Collection & Transport of specimens for Biochemistry examination

2. Patient Preparation Instructions

3. Needle Stick Injury- Care & Precaution

4. Specimen Acceptance & Rejection criteria

5. Treatment & Disposal of BMW

6. House Keeping Procedure

7. Personnel Safety Procedure

8. Sample Preparation and storage

9. Sample Collection

10. Sample rejection

11. General departmental procedure

12. Quality control procedure

13. Equipment maintenance & operating procedure

14. Measurement of uncertainty

15. Critical Alert Level Values/Panic Values

16. Repeat Test

17. Data Backup Plan

18. Monitoring Turn Around Time

19. Generation of test results

20. Housekeeping

21. Personal protection and safety

22. Treatment and disposal of Biomedical waste

23. Data Backup plan , Linearity and range of testing ,

A. Quality Manual (QM)

B. Quality System Procedures (QSP)

1. Receipt, Handling, Storage and Disposal of samples

2. Control of documents

3. Service agreements

4. Selecting and evaluating referral laboratories

5. Purchase

6. Management of complaints or other feedback 7. Identification and control of non-conformities

8. Corrective Action

9. Preventive Action

10. Control of records

11. Internal Audit

12. Management Review

13. Personnel and training

14. Facility maintenance and environment

15. Selection, purchasing and management of equipment

16. equipment maintanance

17. Calibration of equipment

18. management of reagents and consumables

19. Pre-examination process

20. Collection and handling of primary samples

21. Transportations of samples

22. Pre-examination handling, preparation and storage

23. Validation of examination procedures

24. Ensuring the quality of examination results

25. Review of examination results

26. Maintenance and safe disposal of clinical samples

4

Accuracy & precision

24. Equipment calibration plan procedure

25. Test procedure – Biochemistry

26. Test procedure – Haematology

27. Test Procedure – Clinical Pathology

28. Test Procedure- Serology

29. Test Procedure – Histopathology

30. Test Procedure – Cytopathology

D. Exhibits

1. Hand Hygiene

2. Order of Draw

3. BMW Management

4. Spill Management

5. Needle Stick Injury

E. Formats

1. Communication with staff

2. Document Distribution Record

3. Revision History of Documents

4. Service Agreement Deviation Form

5. Agreement-Part Time Consultants

6. Ref Lab Evaluation Format

7. Sample Outsourced Format

8. Advisory Services Format

9. Internal Complaint Format

10. Feedback Form — Patient

11. Daily Non conformance Report

12. Corrective Action Form

13. Preventive Action Form

14. Continual Improvement Form

15. Qulaity Indicators

16. Turn Around Time

17. Audit Schedule

18. Audit Non conformance Report

19. Internal Audit Report

20. Risk Assessment Form

21. Management Review Minutes

22. Confidentiality Agreement

23. Employee health record

24. Induction Training Format

25. Annual Training Plan

26. Training need identification

27. Meeting / Training Attendane

28. Training Questionnaire

29. Incident / Accident Record

30. Employee training record

31. Employee Suggestion Form

32. Employee competency assessment form

33. Employee Performance Appraisal Form

34. Employee personnel record

35. Employee Joining Letter

36. Temperature / Humidity Record Format

37. Housekeeping schedule

38. Toilet Cleaning Schedule

39. Waste Disposal Record

40. Equipment service log

41. Maintenance Schedule - Equipment

42. Decontamination Schedule - Equipment

43. Verification Format - Equipment

44. Lot Verification format - New Kit

45. Test Requisition Form

46. Sample Rejection Record

47. Validation & Verification Record

48. External QC Corrective Action Record

49. Internal QC Corrective Action Record

50. Sample Discard Record Format

51. Report Error Log

52. Critical / Alert Value Information Record Format

53. Software Validation & Verification

54. Charges Record

F. Audit Checklist (Technical & Management Clauses)

G. Internal Quality Control (IQC)

H. External Quality Assurance Scheme (EQAS)

I. Pre analytical & Analytical concerns

J. Key issues in Lab

One Days (Sta�s�cs)

1. Statistics - Basic Concepts

2. Evaluation & IQC - LJ Charts & westgards rules

3. Evaluation & EQC - including Z Score

4. Inter Equipment comparison

5. Regression Analysis

6. Correlation Coeffective

7. Six Sigma - Concepts & Application

09:30 - 10:00 am

10:00 - 11:00 am

11:00 - 11:30 am

11:30 - 12:30 pm

12:30 - 01:00 pm

01:00 - 02:00 pm

02:00 - 03:00 pm

03:00 - 03:30 pm

03:30 - 04:00 pm

If any query kindly contact : Trip� Madan - 9958697309 | Dr. Neeraj Jain - 9810492621, 9313679026If any query kindly contact : Trip� Madan - 9958697309 | Dr. Neeraj Jain - 9810492621, 9313679026If any query kindly contact : Trip� Madan - 9958697309 | Dr. Neeraj Jain - 9810492621, 9313679026

09:30 - 10:00 am

10:00 - 11:00 am

11:00 - 11:30 am

Registra�on & Introduc�on

Quality in Clinical Lab

11:30 - 12:15 pm

12:15 - 01:00 pm

01:00 - 02:00 pm

02:00 - 03:00 pm

03:00 - 04:00 pm

Review of ISO 15189

Prepara�on of Manuals (QM, SOP & QSP)

Forms & Formats

Lab Safety Manual

Review of Day 1

How to Start a Laboratory??

Pre Analy�cal & Analy�cal Concerns

Selec�on of New Equipment

520101243865011

Key Issues in Lab

Concepts of IQ, OQ & PQ

Valedictory

09.00-09.30 am

09.30-10.00 am

10.30-11.30 am

Registra�on & Introduc�on

Sta�s�cs – Basic Concepts

DAY 3 - (STATISTICS IN CLINICAL LAB)

Internal Quality Control (IQC)— • Evalua�on (LJ Charts & Westgard’s rules) • Root Cause Analysis (RCA) • Correc�ve Ac�on (CA)

External Quality Assurance Scheme (EQAS) — • Evalua�on (Z Score) • Root Cause Analysis (RCA) • Correc�ve Ac�on (CA)

Inter equipment comparison

Correla�on coefficient & Regression Analysis

Six Sigma (Concepts & Applica�on)

11:30 - 12:00 pm

12:00 - 01:00 pm

01:00 - 01:30 pm

01:30 - 02:30 pm

02.30-03.00pm

03:00 - 04:00 pm

MELAP

:

:

:

:

:

:

Cheque or D/D should be sent at

A2/194, Near Police Station, Paschim Vihar,

New Delhi-110063

DR. NEERAJ JAIN

For Registra�on : Trip� Madan - 9958697309

520101243865011

Timings : 9.30 am to 4.00 pm

City: ____________________ Date ____________________

Programme Detail Type : 2 Day 1 Day 2+1 Day

Ref.Mobile Mail SMS Friends Social Media

PAYMENTSl No. Programme Type

1.

2.

3.

2 Day

1 Day

2+1 Day

For Doctor's

4000/-

2000/-

5000/-

For Technical Staff

3000/-

1500/-

4000/-

Payment should be remitted either through DD/ Po/ A/c payee Multicity Chequein favour of "MEDICAL EDUCATION & LEARNING POINT"

Payable at New Delhi