Pro�ciency Testing (PT) Part 2:

Investigating Failures

Last month we discussed the rules and requirements for how to properly
perform pro�ciency testing (PT) within your laboratory. In part 2 of this 3-part
series we’ll review the rules associated with evaluating your results, and how to
investigate any unsuccessful surveys. Still to come in part 3 we will look into
how to utilize your PT results to monitor for trends and shifts in your values.

The rules:

• Performance Review: Laboratories must initiate and document a review of

their PT performance evaluations within 2 weeks of noti�cation that results
are available. This includes a review of both graded and non-
graded/educational analytes and events as well.

Key things to note: Even though educational samples are not formally graded,
you should still verify the accuracy of your results, with appropriate follow-up
for any failures. CAP speci�cally requires you to evaluate these educational
challenges as well. Whether the sample is graded or not does not change the
fact that you had an incorrect result.

• Unsatisfactory Performance: For any unsatisfactory results, you are required

to perform a root cause analysis to determine why (see below for guidance).
This also includes any clerical errors – you need to evaluate your process and
�nd ways to prevent these simple errors from happening again. If they are
happening with PT samples, it is possible they are happening with patient
samples as well.

• Cessation of Patient Testing: Unsatisfactory events indicate that there was a

problem with that particular survey; whereas unsuccessful events indicate
there has been a pattern of unsatisfactory events/samples and a larger
 problem exists. If a pattern of poor performance is detected, you may be
asked by your local state department of health to cease all testing for a
particular analyte.

Key things to note: This also applies to clerical errors. Even if there was no
technical problem with the accuracy of your results, failure to submit results on
time or clerical errors made while submitting can also have severe impacts on
your ability to continue o�ering that test.

• Remedial Action: If you’ve been noti�ed by your PT provider or state DOH to

cease testing, there are extensive steps that must be completed to prove that
the problem was correctly identi�ed and corrected. You must also identify
where samples will be referred to for tests you are unable to perform in-
house.

Key things to note: If testing has been removed from your laboratory, you will
be required to demonstrate successful performance in 2 consecutive PT survey
events for the analyte(s) in question before being granted permission to resume
patient testing. This can cause signi�cant delays and �nancial impact for your
organization.

Root Cause Analysis: Investigate to determine who, what, why, when, and how
the event occurred. Be sure to evaluate all phases of testing to ensure you
identify all potential causes.

• Pre-Examination:
• Human Resources – evaluate the training and competency records for
sta� involved in the handling and testing of samples.
• Facilities – reagent inventory control & storage temperatures, equipment
maintenance and function checks
• Standard Operating Procedures (SOPs) – sta� compliance with written
policies, bench excerpts are current and valid, document version control
up to date
• Specimen –test requisition/order entry (was the correct test code
ordered/performed?), labeling (were aliquot/pour o� tubes properly
labeled?), transport (was appropriate temperature requirements
 maintained until testing performed), quality (was there visible
deterioration with the sample prior to testing or cracked/damaged tubes
received?), quantity (was the original sample spilled or leaking causing an
incomplete aspiration of sample by your instrument?)

• Examination:
• Method Validations – were instruments current with calibration
requirements, any bias noted during instrument correlation studies,
values being reported within the veri�ed AMR
• Environmental Controls – temperatures/humidity within tolerance limits,
for light sensitive studies (bilirubin) was there excessive exposure of the
samples to light prior to testing, excessive vibrations occurring that may
have a�ected results (nearby construction or a running centrifuge on a
shared work bench)
• Quality Control – did QC pass on the day of testing, was QC trending or
shifts noted that month
• Analytical Records (worksheets) – were sample results transcribed
correctly between the analyzer and worksheet, between the worksheet and
LIS
• Instrument Errors – were any corrective actions or problems noted for the
days before, during, or immediately after testing of PT occurred
• Testing Delay, Testing Errors – were samples prepared and not tested
immediately leaving them exposed to light or air which may a�ect results
(blood gas samples), any errors or problems noted during testing that may
have caused a delay or a�ected accuracy of results

• Post-Examination:
• Data & Results Review – check for clerical errors, was data trasmitted
correctly from the instrument into LIS, was data entered correctly on your
PT provider entry submission forms
• Veri�cation of Transmission – did your results correctly upload to the PT
provider website, was there an error or failure with submission
• Review of LIS – are your autoveri�cation rules set up correctly, is the
autoveri�cation validation current with no known issues
• Patient Impact – perhaps the most important step to take when reviewing
PT failures, you need to determine what impact your failure had on your
 patient results. Depending upon the identi�ed root cause and how
di�erent your values were from the intended response, this can
potentially pose a severe impact on your patient values tested at the same
time as the PT samples.

Involve your medical director to determine if the discrepancy in results is

clinically signi�cant. Perform a patient look-back to review patient values for
the same analyte with the failure during the time period in question. Evaluate
the bias that was present, and if deemed to be clinically signi�cant then
corrected patient reports will need to be issued with a letter from the medical
director explaining why. If it was decided that the discrepancy is not clinically
signi�cant, document this in writing and keep on record with your complete
investigation response.

Corrective Actions/Preventative Actions – use the following set of questions to

help guide you in ensuring that the problem identi�ed during your root cause
analysis will not occur again:

• What changes to policies, procedures, and/or processes will you implement

to ensure there will not be a repeat of this problem?
• Do any processes need to be simpli�ed or standardized?
• Is additional training or competency assessment needed? If so, identify
speci�c team members to be trained, and who will be accountable for
performing and documenting this training.
• Is additional supervisory oversight needed for a particular area or step?
• Are current sta�ng levels adequate to handle testing volumes?
• Would revision or additional veri�cation of the LIS rules address or prevent
this problem?
• How can the communication between laboratory, nursing, and medical sta�
be improved to reduce errors in the future?

Continuous Process Improvement – after identifying the true root cause(s) for
the failure and implementing corrective/preventative actions, you need to
evaluate the e�ectiveness of those improvements. Have they been sustained?
Are they working to correct the original problem? Have you created new
problems by changing the previous process?
• Quality Management Meetings – if necessary, increase the frequency of
these meetings during the evaluation period for timely feedback to
management and sta�
• Implement internal audits and quality indicators to check for potential issues
• Access the specimen transport conditions to ensure they meet test
requirements
• Evaluate and monitor your turnaround time metrics to track problem
specimens and impact of testing delays
• If necessary, increase the frequency when QC is performed or calibration
frequency if stability issues are identi�ed

Performing a thorough root cause analysis for any failures will allow you to
implement appropriate corrective actions that will address the true issues.
Having a robust quality management program will help ensure these issues are
identi�ed and corrected in a timely manner, and reduce the potential for the
dreaded Cessation of Patient Testing letter from your local DOH.

Coming up in the �nal installment of this series on PT testing, we’ll review all
of the quality indicators and data that can be found in your PT evaluation
reports to help ensure you’re on track for accurate patient values.

-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty
recognition program. She has worked in the medical laboratory profession for over
18 years. In her current position, she transitions between performing laboratory
audits across the entire Northwell Health System on Long Island, NY, consulting for
at-risk laboratories outside of Northwell Health, bringing laboratories up to
regulatory standards, and acting as supervisor and mentor in labs with management
gaps.
April 17, 2019 / generalist, management/administration, pathology / generalist, leadership,
management/administration, pathology, pro�ciency testing

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Investigating Failures”

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