QUALITY IN CLINICAL LAB - melap15189.com · A. Quality Manual (QM) B. Quality System Procedures...
Transcript of QUALITY IN CLINICAL LAB - melap15189.com · A. Quality Manual (QM) B. Quality System Procedures...
A-2B/155A, EKTA APARTMENT, NEAR DIVINE HAPPY SCHOOL, PASCHIM VIHAR, NEW [email protected] 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
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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
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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
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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
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