2. In this presentation you will:
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• Review PT basics
• Learn how to review PT results
• Receive guidance on investigating and resolving PT failures
3. PT Enrollment
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• Ensure that your PT provider has your correct COLA and CLIA ID
• Every CLIA lab must have its own PT enrollment.
• If your practice has satellite labs, each lab must enroll and perform its own
• PT enrollment review should be part of your annual Quality Assessment (QA)
plan.
• Every year, ensure that every “regulated” test offered by the laboratory is
enrolled in an approved PT program and every “unregulated” test is either
enrolled in PT or evaluated by an alternate quality evaluation procedure,
as split specimen testing.
4. PT Enrollment
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• Select a PT provider that has a large peer group for your type of testing.
• ≥10 peers is ideal, but the bigger the better.
• Enroll in the next year’s PT program in approximately November of every year.
• Most enrollments are not automatically renewed, you may need to call your
provider if you do not receive enrollment documents by mid-November each
year.
• Failure to enroll in a timely manner is considered a PT failure.
5. How many PT samples are included?
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• Regulated analytes – 5 samples, 3 times a year
• Unregulated/waived analytes – 2-5 samples, 2-3 times a year
(varies by PT provider)
6. Waived testing
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• PT is not required for waived testing, but is encouraged
• If you choose to participate in PT for waived tests, you must
evaluate any failures
• Prohibition of PT referral to another laboratory and sharing of
PT results DOES APPLY to PT done on waived test methods.
7. IMPORTANT!
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• You MUST treat PT samples in the same manner as you do patient samples. (PT
samples may not be tested in duplicate or triplicate, tested by only your senior tech,
averaged out, etc. unless this practice is also done for patient samples.)
• NEVER send PT samples to another lab for testing. (Test all PT samples up until the
point when the laboratory would normally send a patient specimen to another
laboratory for confirmatory, reflex, or distributive testing.)
• You may NOT communicate with any other laboratory regarding PT samples, results,
etc. prior to the cut off date for submission.
8. How Do I Interpret My PT Results?
Each PT provider’s graded reports vary, but for the most part your PT results should include the
acceptable/unacceptable evaluation of each sample (Diagram 1) –AND- a cumulative evaluation of the analyte
(Diagram 2). Overall, you will need 80% or better to PASS. 100% is required for ABO, Rh typing and compatibility
tests.
Diagram 1 Diagram 2
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9. My PT Results Are Ungraded…Now What?
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Thoroughly look over each result to assess your
performance. Please keep an eye out for artificial scores or
ungraded results. PT providers may not grade an analyte or
give a lab an artificial score in the event there is no
consensus within the peer group or too small of a peer
group (≤10).
10. My PT Results Are Ungraded…Now What?
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If you received any score that is not representation of the labs actual
performance, you must use other means to verify the accuracy of the test.
• Self-evaluation against the PT provider’s participate summary
• Split-specimen analysis
• Participate in a manufacturer’s verification program
• Conduct accuracy studies using materials of a known value (calibrators,
standards, or controls as long as they are not of the same lot number
currently used to verify routine instrument performance)
• Re-analyze saved PT samples
12. PT Corrective Action
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I Failed PT…Now What?
STEP 1 - Determine the root cause for the failure and document findings.
You may need to gather several documents to assist with this task. Review the following items to
assist with identifying the root cause for the failure.
1. Look for any clerical errors such as transposed numbers, misplacement of decimal point,
specimen mix-up, incorrect units of measurement, incorrect method or instrument code,
dilution errors, etc.)
2. Were PT samples received, handled and stored according to the PT providers
instructions?
3. Was there any delay between preparation of the PT sample and actual analysis?
4. Were environmental conditions (temperature, humidity, etc.) appropriate on the day of
testing?
13. PT Corrective Action
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I Failed PT…Now What?
STEP 1 - Determine the root cause for the failure and document findings.
5. Any problems or recalls associated with test kits, reagents, controls, standards that were
used to test the PT samples?
6. Was QC, maintenance, calibration/calibration verification within range and showing no
bias?
7. Who performed testing? Has the individual been properly trained and determined to be
competent?
8. Re-test the PT samples. Are the results acceptable now? If yes, determine if any changes
to components of the testing system changed since the PT samples were originally
tested? (calibration, parts replaced, change in reagents, etc…)
14. PT Corrective Action
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STEP 2 – Implement corrective action and document actions taken.
Your corrective action should directly resolve the identified root cause. You may also use this
opportunity to see if the corrective action is something that can be implemented with patient testing
testing to improve your processes. If your corrective action required changing of instrument parts,
lot numbers, calibrations, etc., it may be wise to obtain an off-scheduled or remedial PT samples to
confirm that the corrective actions taken were effective.
STEP 3 – Evaluate patient impact and document findings.
Depending on the root cause, you may want to review patient results that were tested around the
time of PT, and determine if patient results were affected or have the potential to be affected in a
similar manner as PT samples. If patients were impacted, you must notify the providers and
document corrective actions taken.
15. PT Corrective Action
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STEP 4 – Share your findings
Please share your findings and corrective actions taken with ALL laboratory personnel. Everyone should
should be aware of steps taken to prevent reoccurrences.
STEP 5 – Sign, date and file
All supervisory and testing personnel, as well as the Laboratory Director, need to sign and date your
corrective action write up. File your corrective action write up and supporting documentation in your PT
binder for review by your surveyor or accrediting organization upon request.
16. PT Corrective Action
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1st, 2nd, 3rd Failure…What Does This Mean?
Unsatisfactory performance – 1st time failure for an analyte, specialty, or subspecialty.
• Perform corrective action and file in your PT binder for review by your surveyor.
Unsuccessful performance – 2nd time failure for an analyte, specialty, or subspecialty in 2 consecutive or
2 of 3 testing events. (Example: Fail – Fail or Fail – Pass - Fail)
• Perform corrective action and submit a copy to COLA for review.
Repeat Unsuccessful performance – 3rd time failure for an analyte, specialty, or subspecialty in 5 testing
events*.
(Example Fail–Fail–Fail, or Fail–Pass–Fail–Fail, or Fail-Fail–Pass–Fail or Fail-Pass-Fail-Pass-Fail)
• Cease testing immediately (6 month cease for regulated analytes). Perform corrective action.
Follow reinstatement procedures.
(* Two consecutive passes resets count. Example: Fail-Pass-Pass-Fail = unsatisfactory performance)
17. PT Corrective Action
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THINGS TO REMEMBER
PT failures can be a good thing! It opens an opportunity for the lab to review
and improve their pre-analytical, analytical and post-analytical processes.
PT may identify areas where more attention or resources are needed.
All PT documentation must be maintained for a minimum of 2 years (3 years for
for California).
18. Thank you
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We are available to assist with any questions you
have about investigating PT failures.
• Call us at 800-981-9883
• Email us at labsupport@cola.org
REV 10/2020
