1. 1 Accreditation and Certification: Definition  Certification: Procedures by which a third party gives written assurance that a product, process or service conforms to specific requirements.  Accreditation: Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.

2. 2 Accreditation and Certification: Definition  Certification: Procedures by which a third party gives written assurance that a product, process or service conforms to specific requirements.  Accreditation: Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.

3. 3  The Accreditation body which oversees the assessment and grants accreditation (and may also set the standards)  The Standards with which a laboratory has to comply in order to gain accreditation  The Assessors or Inspectors who seek to establish compliance with the standards by conducting the assessment  The User Laboratory which is required to, or voluntarily seeks to, comply with the standards by being assessed. Accreditation: Elements

4. Non-conformity Management

5. 5 Objectives On completion of this session the reader will: 1. Understand the term “Non-conformity”. 2. Know the essential monitoring tools. 3. Know preventive actions, remedial actions, and corrective action and why they are associated and different.

6. 6 To show presence of control:  Say what you Do,  Do what you Say,  Write it!

7. 7 Definitions ISO 9001-2000  Audit  Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.  Vertical Audit and Horizontal Audit  Non-conformity  Non-fulfillment of a requirement  Corrective action  Action taken to eliminate the cause of a detected non-conformity or other undesirable situation  Preventive action  Action taken to eliminate the cause of a potential nonconformity or undesirable potential situation  Continual improvement  Re-occurring activity to increase the ability to fulfill requirements

8. 8 The Quality System Process Control (Quality Control & Specimen Management) Purchasing & Inventory Assessment Non- conformity Management Information Management Process Improvement Customer Service Facilities & Safety Organization Personnel Equipment Documents & Records

9. 9 What is a Non-conformity - Any event that has a negative impact on an organization, which includes personnel, product, equipment, or the environment. - Can arise in two distinctive ways “Reactive audits” and “Proactive audits”  Major non-conformity  Minor non-conformity

10. 10 What are common laboratory non- conformities?  Patient identification error  Lost specimen  Late specimen  Contaminated samples  Performing a wrong test  Performing a test inconsistent with the written procedure  Proficiency Testing error  Out of Range Controls  A false negative result  Late reports  Errant reports  Received complaints  Laboratory safety accident  A “near miss”

11. 11 Why Do Errors Occur? Some causes include:  Individual responsibilities unclear  No written procedures  Written procedures not followed  Training is not done or not completed  Checks not done for transcription errors  Test kits not stored properly  QC, EQA not performed  Equipment not properly maintained Errors can occur throughout the testing process

12. 12 Pre-testing Errors Examples include:  Wrong specimen collected  Specimen mislabeled or unlabeled  Specimen stored inappropriately before testing  Specimen transported inappropriately  Reagents or test kits stored inappropriately

13. 13 Testing Errors Examples include:  Established algorithm not followed  Incorrect timing of test  Results reported when control results out of range  Improper measurements of specimen or reagents  Reagents stored inappropriately or used after expiration date  Dilution and pipetting errors

14. 14 Post-testing Errors Examples include:  Transcription error in reporting  Report illegible  Report sent to the wrong location  Information system not maintained

15. 15 Consequences of Laboratory Error  Inadequate patient care  Death  Inappropriate public health action  Undetected communicable disease outbreaks  Wasteful resources

16. 16 The non-conformity Cycle INVESTIGATE ACTIONCOMMUNICATE AWARENESS

17. 17 The non-conformity Cycle AWARE INVESTIGATE REMEDIATECORRECT PREVENTION MONITOR

18. 18 How are non-conformity detected? Process Monitoring Quality control L-J Charts Management Review Internal Audit Safety Quality External Audit PT/EQA Accreditation Quality indicators Delayed reports Interpretation errors Monitoring complaints and satisfaction surveys

19. 19 How are non-conformity investigated? Information gathering Thorough investigation Root cause analysis

20. 20 Root Cause Analysis Structured investigations that focus on identify the underlying true causes of occurrences. Root Cause Analysis can lead to effective occurrence resolution.

21. 21 Root Cause Analysis Tools Every cause has a deeper reason. For each occurrence seek 5 levels of explanation before being satisfied as to the true (root) cause MANPOWEREQUIPMENT METHODSENVIRONMENT RESULT

22. 22 How are non-conformity Corrected? Remedial Actions  What are the immediate consequences of the error that require amendment.  What are the direct, secondary consequences of the error the require amendment. Corrective Actions  What needs to be in place to prevent this error from happening again?

23. 23 Non-conformity Management Learn from the event and avoid its recurrence Preventive Actions Corrective Actions Remedial Actions See the potential event and plan to avoid it Address the event and its consequences

24. 24 Preventive Actions  Preventive actions are planned  Preventive actions require team participation  Preventive action tools take into consideration:  Probability  Safety  Risk

25. 25 Non-conformity Management Process Develop a system for prompt investigation of every laboratory problem and error: 1. Establish a process to detect all problems  Remember that you may not be aware of problems unless you look for them 2. Keep a log of all problem events 3. Investigate causes, analyze information

26. 26 Non-conformity Management Process 4. Take corrective action 5. Keep records of findings and action in log 6. Observe for recurring problem – systemic 7. Provide information to those affected by the problem or error

27. 27 One example of a non-conformity Management Form

28. 28

29. 29 Quality Monitoring Tools Process Monitoring Management Review Internal Audit External Audit Quality indicators Monitoring complaints

30. 30 In summary… The non-conformity Cycle AWARE INVESTIGATE REMEDIATECORRECT PREVENTION MONITOR