1. Proficiency Testing : A guide to Improve Laboratory Standard
Sasiwimol Ubolyam
HIV-NAT Research Laboratory/Chula CRL

2. After this training, participants should
Discuss 4 GLPs that can help maintain successful proficiency test performance
Discuss 5 proficiency testing practices that can help avoid proficiency test failures
List 5 steps to follow when investigating an unsatisfactory proficiency test result

3. External Quality Assurance (EQA)
EQA is a means of evaluating a laboratory's performance through analysis of unknown samples provided by an external source.
Blinded samples sent on a regular schedule
Run as patient samples
Results are compared to peers
SMILE provides EQA through one or more organizations based on testing capabilities. If the laboratory is using EQA through an in-country provider we will review the events or provide the additional resources. 3

4. PT History The first PT event occurred in 1946
1967 , the Clinical Laboratory Improvement mandated PT for all laboratories
CLIA’ 88 specifies performance standards laboratories must achieve.

5. EQA cycle Pre-Analytic Post-Analytic Creation Acquisitionor
Acquisition
Quality Control
and
Validation
Sample
Send-out
Laboratory
Processing
Results
Receipt
Analysis
Client
Reports
Challenge Selection
Pre-Analytic
Post-Analytic
Slide 11
For the rest of this presentation I would like to briefly take you through the EQA cycle. Just as the laboratory cycle is divided into the pre-analytic, analytic, and post-analytic phases. A similar structure is seen with the EQA cycle.

6. Sometimes, the best plan is a blended co-share solution.
Purchase or Produce
Produce
Meet specific needs
Meet regional needs
Ensure quality
Need Infrastructure
Requires larger staff budget
Need special location and equipment
Purchase
Easier
Less expensive
Import and Transport issues
May not address regional issues
Slide 13
The next critical decision is whether it is better to purchase the materials that your program wants to challenge, or make them yourself, or consider a combination of the two. Clearly there are advantages and disadvantages to all three sides. Each program ultimately will make the decision on their own. As a guide, I only encourage you to consider only materials that will address the specific needs for your participants, in your geographic local.
Sometimes, the best plan is a blended co-share solution.

7. Regulations
Satisfactory performance as a score of 80% of results within acceptable limits (4 acceptable results out of 5 samples) in a single proficiency testing event for most analytes
For ABO/Rh blood groups and compatibility samples, 100% of results must be within acceptable limits.

8. Regulations
Unsatisfactory performance occurs when a laboratory scores less than 80% (or less than 100% for ABO/Rh and compatibility samples) in a single proficiency testing event.
Unsuccessful proficiency test performance occurs when a laboratory fails to achieve a satisfactory score on 2 consecutive PT events, or 2 out of 3 consecutive PT test events

9. Regulations
Laboratories designated as unsuccessful must resolve the problem and successfully complete 2 PT events before continuing to test patient samples

10. Preventing Proficiency Testing Failures
Good Laboratory Practices can help achieve successful performance on PT events
Ensure the staff are adequately trained
Use quality control methods that will regulate the instrument within the performance range specified by the manufacturer
Validate the instrument’s analytical measurement range as specified by CLIA’88 regulations, or more often if recommended by the manufacturer.
Follow consensus guidelines issued by scientific panels

11. Preventing Proficiency Testing Failures
Proficiency Testing Tips : 5 commonsense PT practices can also help avoid errors
Confirm your laboratory is assigned to the correct peer group
Mark the shipping dates for PT samples on calendar
Avoid specimen handling and clerical errors.
Submits results by due date
Review standard deviation index (SDI) data on the evaluation supplied by the PT provider

12. CAP Evaluation What Should You Review?
Evaluate each analyte and specimen for negative/positive bias, trends or shifts
Evaluate ungraded challenges
If an evaluation criteria is not listed in the Participant Summary you can use information provided by manufacturer

13. Review Results to Prevent Failure

14. Education Challenges Code 26
POC Phase II N/A YES NO
Is there evidence of evaluation and, if indicated, corrective action in response to "unacceptable" results on the proficiency testing reports and results of the alternative performance assessment system?
NOTE: The evaluation must document the specific reason(s) for the "unacceptable" result(s) and actions taken to reduce the likelihood of recurrence. This must be done within one month after the POCT program receives its evaluation. In addition, each ungraded challenge, each educational challenge, and each episode of nonparticipation must be reviewed and corrective action instituted as appropriate.

15. SDI algorithm
If no more than 1 of the 5 SDIs exceeds the same (+1 or – 1) SDI limit, significant error is unlikely and further scrutiny is not needed
If 2 or more SDIs exceed the same (+1 or -1) SDI limit, calculate the average SDI. If the average SDI is greater than 1.5, a significant systemic error is possible.
If the average SDI is less than 1.5, check whether 1 observation exceeds 3 SDI or the difference between the largest and smallest SDI exceeds 4.0 if either of these conditions exists, a significant random error is likely.

16. Reasons for Failure

17. Troubleshooting Proficiency Test Failures
Each unsatisfactory result should be investigated even if the laboratory’s overall performance is successful
Because this will help detect and correct problems before they progress to unsuccessful performance in the future

18. Troubleshooting Proficiency Test Failures
To find the reason for an unacceptable result, you may need to examine the result form or retest specimen.
Therefore , you should always keep a copy of the result form and instrument printouts or result logs and save the PT samples (usually frozen)

19. Investigate Unsatisfactory Results Thoroughly
Look for clerical errors : Check result for evaluation is the same as result form, selected the correct instrument, reagent, or kits and transcribed results correctly, verify units
Investigate possible specimen handling problems : verify specimen arrived in acceptable condition
stored according to instructions, reconstitute correctly
tested within time allow for specimen stability, examine specimen hemolysis.
Notify PT provider if you suspect that a problem with specimen handling occurred during manufacture or transit

20. Investigate Unsatisfactory Results Thoroughly
3. Investigate possible operator errors : such as mishandling dilutions, misinterpretation instrument codes, and in correctly loading or sampling the specimen.
Dilution errors were the most common operator in some study

21. Investigate Unsatisfactory Results Thoroughly
4. Review reagent logs, quality control logs and calibration records :
to look for evidence of instrument or kit malfunction, check expire date , examine refrigerator and room temperature records.
Verify that controls were within acceptable limits and that there were no indications of shifts or trends.
Make sure that the instrument had been properly calibrated with in time frame recommended by the manufacturer. Calibration verification had been performed as recommended by manufacturer.
Also check whether the instrument was calibrated during the interval between the PT test event

22. Investigate Unsatisfactory Results Thoroughly
5. Review instrument maintenance records. : Look for the indications that the instrument may not have been performing optimally on the day samples were tested.
Also look for changes that could have impacted performance.
Check for maintenance performed after the PT event which may have corrected a problem that had not been detected on the day samples were tested.

26. Example: Investigation Form

27. Root cause analysis
The goal of an investigation is root cause analysis and prevention of further failures.
We often help labs discover problems by prompting them to probe deeper into EQA failures.
We push them to find the cause of a failure and fix it, so that the integrity of patient testing is ensured. 27

28. Conclusion
Since the 1st PT Test event in 1946, PT has become a critical tool to evaluate performance and judge whether a laboratory is sufficiently proficient to reliable test patient samples.
No longer voluntary, successful participation in a PT program is now required of all laboratories that test patient specimens
The best strategy for maintaining successful performance is to use good laboratory practices to prevent or correct problems early, pay attention to proficiency testing details to avoid clerical and sample handling errors, and investigate unsatisfactory results thoroughly and methodically

29. Proficiency Testing Exception Summary (PTES)
Unsatisfactory PT performance
Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event.
Unsuccessful PT performance (2 of 3 testing events)
Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two of three consecutive testing events.
Critical PT performance (3 of 4 testing events)
Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for three consecutive or three of four consecutive testing events. A laboratory must immediately cease testing for that analyte or the discipline.

30. The Benefits of PT/EQA Health Care System The Laboratory The Patient
A valuable assessment tool
An indicator of laboratory performance
A mechanism to provide notice and education
The Laboratory
A valuable tool for: education
Self assessment
System confidence
Public confidence
Slide 5
Why perform such a service? Monitoring EQA provides benefits to all involved. Done properly, It truly create a win-win-win result.
The Patient
Knows the system is working together to ensure the public receives accurate and useful information

31. EQA
Information
Education
Quality Management