1. به نام خدا

2. مديريت رخدادها و موارد عدم انطباق درآزمايشگاه
مديريت رخدادها و موارد عدم انطباق درآزمايشگاه
دکتر نوش آفرين صفادل
اداره مديريت تضمين کيفيت
آزمايشگاه مرجع سلامت

3. What is a Non-conformity or Occurrence ?
Any event that has a negative impact on
an organization,
which includes service, product, equipment, personnel or the environment

4. Where do nonconformity occur ?
THE PATIENT Test selection
Sample Collection
Pre-examination Phase
Sample Transport
Laboratory Analysis Examination Phase
Report Transport
Report Creation
Result Interpretation Post-examination Phase

5. Common causes of error 5

6. Consequences of Laboratory Error

7. What types of nonconformity ?
Major non-conformity
Minor non-conformity

8. How do we encounter Nonconformities ?
Reactive
Proactive

9. How are occurrences detected ?
Management Review
Quality indicators
Monitoring complaints
and satisfaction surveys
Internal Audit
Quality systems require review of the whole operation through regular and constant use of internal audits, external audit, monitoring of process and procedures, including the use of quality indicators and complaints and satisfaction. Top management must regular review the results of audits and monitoring (Management Review) to determine the health of the program and to set the course for further action.
READING – INTERPRETATION – COMMUNICATION ERRORS
External Audit PT/EQA
Accreditation
Process Monitoring Quality control

10. Error
Correction /
Remedial Actions

11. How are occurrences investigated?
Information gathering
MANPOWER
EQUIPMENT
METHODS
ENVIRONMENT
RESULT
Information gathering includes checking records, holding interviews, requesting written reports to determine how an event occurred.
A thorough investigation results in the compilation of the information gathered and a decision being made as to cause.
A Root cause analysis (the subject of the next 2 slides) examines the compiled information, and determines the likely cause of an event, and then looks at what were the factors to lead that cause to initiate a problem. A true root cause analysis looks at each potential cause through at least 5 levels to determine the TRUE UNDERLYING (ROOT) CAUSE that lead to an event.
For example:
Problem: A laboratory report was sent out with erroneous information that required recalled and amendment.
Cause 1: The erroneous information was sent out without being checked by a supervisor
Cause 2: The report was sent out by a new employee who did not know the information was supposed to be checked
Cause 3: The employee did not know the information need to be checked because he had not been informed or trained
Cause 4: The employee was not trained because the laboratory educator was off-work and there was not replacement
Cause 5: There was no replacement because the supervisor had not appointed one.
Root Cause Analysis: A laboratory report was sent out with erroneous information because training was incomplete because there was no policy to ensure that trainers were available to ensure the training of new technologists was completed before they were allowed to work independently
Possible solutions:
A-Ensure that a training schedule provides a trainer for each day.
B- Do not allow people to perform tasks independently unless they have completed all necessary training.
C- Investigate when the laboratory has sufficient trainers to ensure that new employees can be trained properly

12. Root Cause Analysis
Structured investigations that focus on identifying the underlying true causes of occurrences
every cause has a deeper reason
for each occurrence seek 5 levels of explanation, asking WHY, before being satisfied as to the true (root)
cause

14. Occurrence Management
Preventive
Actions
Corrective Actions
Remedial Actions
See the potential event and plan to avoid it
Address the event and its consequences
Learn from the event and avoid its recurrence
Nonconformity

15. Keep a log of all problem events Keep records of action in log

16. Occurrence Management Process
1. Establish a process to detect problems
2. Log findings and actions
6. Provide information to all needing it
3. Investigate
causes, analyze
information
4. Take appropriate action
5. Monitor for recurring problems

17. The Occurrence Cycle
Awareness
Communicate
Investigate
ACTION

20. One example of a non-conformity Management Form