به نام خدا

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

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

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

Common causes of error 5

Consequences of Laboratory Error

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

How do we encounter Nonconformities ? Reactive Proactive

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

Error Correction / Remedial Actions

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

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

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

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

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

The Occurrence Cycle Awareness Communicate Investigate ACTION

One example of a non-conformity Management Form