Regn. No. society/west/2014/8901359

MEDICAL EDUCATION & LEARNING POINTMEDICAL EDUCATION & LEARNING POINTMEDICAL EDUCATION & LEARNING POINT(MELAP)

QUALITY IN CLINICAL LABQUALITY IN CLINICAL LABQUALITY IN CLINICAL LABConcepts & Application

(2 Day Training Programme)

Dr. Neeraj Jain : - 9810492621, 9313679026

A-2B/155A, Ekta Apartment, Near Police Station, Paschim Vihar, New Delhi-110063

E-mail : drjain12@yahoo.com | www.melap15189.com

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ABOUT MELAP

Medical Education & Learning Point (MELAP) is an independent body registered under

society act, Govt. of India Registration No.: SOCIETY / WEST / 2014 / 8901359.

It is started to enhance the quality in the healthcare of society through training of

personnel working in laboratory medicine. This training is based on International

Standard ISO 15189 which is designed to assess quality & competence of medical

laboratories. This create value addition to our stakeholders.

Dr. Neeraj JainMBBS, MD., (Path)

• President & Course Director MELAP

• Senior pathologist running NABL accredited lab in west Delhi.

• Graduate & post graduate of University College of Medical Sciences Delhi

• Secretary, Association of Practicing Pathologists

• Lead faculty in more than 200 training programmes all over India

including institutions like AIIMS Delhi, PGI Chandigarh, PGIMS Rohtak,

GCRI Ahmedabad, Neigrihms, shillong and many such places.

• Member, Governing Council, Association of Indian Laboratoris (AOIL)

• Guest faculty in various National Conference

• NABL assessor, NABH assessor

• Trained in ISO 15189 (NABL), ISO 17043 (NABL), ISO 13528 (NABL)

• Green belt in six sigma & lean concept from Indian Statistical Institute.

• Received IMA award of merit for his distinguished services in lab

quality education.

• Received IMA National award - 2014 for lab quality education.

• Received DMA President award - 2014 & 2017

• Received award at CMC Vellore for research paper in Haematology

OUR ACADEMIC AND

MANAGEMENT COMMITTEE

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• Personal involvement & commitment• Optimum Charges• Professional Approach• Delivering contents in simple language• Concept building with examples

Faculty is committed for:

About Program:

• Contains all necessary document and comply with the requirements of ISO 15189:2012.

• • Helps to make documentation easily User friendly and easy to learn

• Developed under the guidance of experienced experts

• Provides model of a management system that is simple

CONTENTSList of documentsA. 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 28. Reporting the results 29. Release of examination results 30. 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, 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

CONTENTS

30. Test Procedure – CytopathologyD. Exhibits 1. Hand Hygiene 2. Order of Draw 3. BMW Management 4. Spill Management 5. Needle stick InjuryE. 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. Quality 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 Attendance Sheet 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 RecordF. Audit Checklist (Technical & Management Clauses)G. Internal Quality Control (IQC)H. External Quality Assurance Scheme (EQAS)I. StatisticsJ. Six Sigma- Concepts & ApplicationK. Pre analytical & Analytical concernsL. Key issues in labM. Selection of new equipment & inter-equipment comparison

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Programme Schedule

QUALITY IN CLINICAL LABQUALITY IN CLINICAL LABQUALITY IN CLINICAL LAB

The registration fee includes Certificate of attendance, Registration Slip, Tea breaks and lunch. This fee does not include any housing.

To register please fill in the registration form and e-mail it back to drjain12@yahoo.com together with a

bank proof of payment of the registration fee. A written confirmation will be sent to all Registrants.

Account Holder : "Medical Education & Learning Point" Account No. : SB/047600101037862 NEFT/IFSC Code : CORP0000476Bank Name : Corporation BankPan No. : AADAM1648JGSTIN No. : 07AADAM1648J2ZHBranch : A-6/9, Paschim Vihar, New Delhi-110063

Payment InformationPayment InformationPayment Information

Registration feeRegistration feeRegistration fee

Payment Detail: Cheque/DD shall be drawn In favour of "MEDICAL EDUCATION & LEARNING POINT" payable at New Delhi.

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

Concepts & Application

Lecture / ActivitiesLecture / ActivitiesLecture / ActivitiesS.NoS.NoS.No TimingTimingTiming

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TEA�BREAK

TEA�BREAK

DAY - 1 DAY - 2Lecture / ActivitiesLecture / ActivitiesLecture / Activities

Introduction to Quality in Clinical Lab

Review of ISO 15189

S.NoS.NoS.No TimingTimingTiming

Review of Day-1

EQAS Interpretation

Understanding of IQC

Forms & Formats

9:30 - 10:00 am

10:00 - 11:00 am

11:00 - 11:30 am

11:30 - 12:30 pm

12:30 - 1:30 pm

1:30 - 2:00 pm

2:00 - 3:00 pm

3:00 - 3:30 pm

3:30 - 4:00 pm

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LUNCH�BREAK

Statistics in Clinical Lab

Selection of New Equipment & Inter equipment Comparison

10:00 - 11:00 am

11:00 - 11:30 am

11:30 - 12:15 pm

12:15 - 1:00 pm

1:00 - 1:30 pm

1:30 - 2:30 pm

2:30 - 3:30 pm

3:30 - 4:00 pm

LUNCH�BREAK

Open House

Six Sigma in Lab Practice- Basics & Application

Key Issues in Lab

for Doctors - Rs. 2500/-

for Technical Staff - Rs. 2000/-

Preparation of Manuals: QM, QSP & SOPs

Pre- Analytical & Analytical Problems in Biochemistry & Haematology

PHOTO

PAYMENT

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Cheque or D/D should be sent at

A2/194, Near Police Station, Paschim Vihar,

New Delhi-110063

DR. NEERAJ JAIN

Name __________________________________________________________________________

Email __________________________________________________________________________

Mobile _________________________________________________________________________

Working Place ___________________________________________________________________

Timings : 9.00 am to 4.00 pm

DD/Cheque/NEFT of Rs. 2500/- for Doctor's & Rs. 2000/- for Technical Staff(Inclusive all) per Participant

QUALITY IN CLINICAL LAB(Concepts & Application)

GSTIN No. : 07AADAM1648J2ZH