General Guidelines Manual, Quality Management, Proficiency Testing Guidelines, QM004

Effective Date: 03/12/2019 Page 1 of 5

Appendix A: Proficiency Test Procedure
Appendix A: Proficiency Test Procedure
This procedure describes:

• Proper handling of Proficiency Testing materials.

• Proper submission of Proficiency test results.
• Review of Proficiency Summary reports.
• Investigation of unacceptable, trending / bias results.
A. Proficiency Test handling (PT)
1. The proficiency test samples must be handled to the same degree as possible as a patient sample would be
handled. Documentation of any special handling that is different from processing patient samples (i.e... necessary
reconstitution, mixing times) is required.
2. Proficiency test samples must be tested with the laboratory’s patient workload by personnel who routinely perform
testing, using the same primary methods systems as for patient /client/donor samples assigned to that bench.
3. Proficiency test samples must be tested the same number of times that patient samples are routinely tested. The
laboratory must use the same procedures for both patient samples and PT samples. NOTE: Do not run PT samples
multiple times if patient samples for that testing are not routinely run multiple times.
4. If PT samples are accessioned to the LIS, do not use CAP in the name.
5. The laboratory must not engage in inter-laboratory communication regarding Proficiency Testing until after the
deadline for submitting results to the proficiency test program has passed.
6. PT samples or portions of samples must not be referred to other laboratories for analysis or evaluation. A laboratory
cannot refer PT samples to another laboratory for confirmatory testing.
NOTE: Be sure that the PT submission deadline has passed before using the samples for cross checking or
educational challenges. Some laboratories internally cross check PT samples by running them on multiple
instruments / methods or they may use the PT samples as a competency by having multiple technologists perform
testing on PT samples. These QA practices can only occur after the submission deadline established by the PT
provider.

B. PT Analysis
1. The method used for proficiency testing must be the primary method or system used for patient testing at the time
the PT event is received. PT samples may be rotated to different instruments or methods after submitting results.
Proficiency samples within each survey event must be performed by the same methodology.
2. If the laboratory (under one CLIA license) uses multiple methods for a analyte, proficiency samples must be
analyzed by the primary method a the time of the PT event, or rotated among primary methods each PT shipment.
Labs under CMS are not allowed to order multiple PT kits for the purpose of testing the same analyte on multiple
instruments of methods prior to the due date for submitting results to the provider.

C. PT Submission
1. Care must be taken when completing the PT result form. Results left blank for any enrolled test or incorrect/missing
test codes or methodology will result in an unsatisfactory performance.
2. All Proficiency test results must be submitted online by the supervisor or his/her designee to the appropriate
Proficiency Testing provider.
3. Check the individual Proficiency Test Program website for online submission procedures.
4. Implement a clerical accuracy review process prior to final submission of all proficiency testing result.
5. If the proficiency test results are being submitted on the due date it must be submitted by MIDNIGHT, (Central
Time).
6. Print a copy of the online submission confirmation. Note 1: Notification of due dates will be forwarded by the CQI
office 5 days prior to the survey due date. Upon receipt, an acknowledgement of receipt response is required. Note
2: Failure to submit PT results to the provider within the timeframe specified by the provider will result in score of 0
for the testing event resulting in unsatisfactory performance.

D. PT Documentation
General Guidelines Manual, Quality Management, Proficiency Testing Guidelines, QM004
Effective Date: 03/12/2019 Page 2 of 5
Appendix A: Proficiency Test Procedure
1. All proficiency testing records (PT data, instrument output, computer sheets, and corrective actions) must be
kept for at least two years onsite and retained for easy retrieval for at least five (5) years.. These records should be
organized in chronological order.
2. The laboratory must document the handling, preparation, processing, examination, and reporting of results for all PT
samples. Keep a copy of all records, including a copy of the results submitted, confirmation of PT submission to the
PT program.
3. The attestation form provided by the PT program must be physically signed by the analyst and the Laboratory
Director or designee, attesting to the integration of the PT samples into the patient workload using the laboratory’s
routine methods.
4. Designees must be qualified though education and experience to meet defined regulatory requirements associated
with complexity of testing as defined in the personnel section of the Laboratory General Checklist.

E. PT Participant Summary Report Review

1. Careful evaluation of both satisfactory or unsatisfactory PT reports, along with active tracking of PT results must be
documented by the laboratory.
2. Most PT events with less than 10 lab participants automatically receive a score of 100%. The laboratory must
not accept this score as having met satisfactory performance. An evaluation of the report must be performed to
demonstrate that the laboratory has met established proficiency testing criteria. The evaluation can be performed by
comparing your laboratory proficiency test results with results documented in the proficiency test result participant
summary report. Ensure that your laboratory results are within:
• the same as the majority percentage of participant labs.
• <= 2 SDI for a numerical analyte of same method/reagent
3. Each PT report generated by a PT program or informal PT program( alternative PT), including any un-graded /
educational survey reports, must be reviewed, dated, and signed by the lab director or designee. When appropriate,
reviewer’s comments must be documented.

F. Investigation of PT Results:
1. Unacceptable: A laboratory may have an occasional unacceptable result. This may reveal a problem in specimen
handling or in an analytical process that will not be exposed by any other means. Therefore, any unacceptable result
must be investigated thoroughly to maximize the opportunity to correct a problem. The laboratory is responsible for
monitoring all PT discrepancies even those results that are non-scored (ungraded) or deemed “educational” by the
PT provider.
When investigating an unacceptable result, there should be a systematic evaluation of every aspect of the
testing process. There are certain points to keep in mind while performing the investigation such as: clerical
errors, methodologic problems, equipment problems, technical problems, problem with PT materials etc. (see table
# 1 “Common Causes of Unacceptable Results”) :
• Gathering and reviewing data
All documentation should be reviewed, and personnel who processed or tested the specimen interviewed. The
investigation should include:
• Review of work sheets indicating testing material condition (satisfactory) upon receipt.
• Record reviews of quality control, calibration status and instrument check (function checks).
• Repeat analysis and calculations (if available).
• Evaluation of the laboratory’s historical performance for the analyte in question.
• Evaluation of patient results/patient impact:
The laboratory must review all patient data generated during the time the unacceptable (PT) was performed.
The laboratory is to determine whether patient care was compromised; and if so, what corrective action is
required. (i.e... if patient result discrepancies are noted upon sample run repeat, the patient’s physician /
provider must be notified).
• Conclusions and Actions:
The laboratory should make every effort to find the cause(s) of an unacceptable result. If the laboratory can
identify an underlying system problem that contributed to the unacceptable result, actions to improve the
General Guidelines Manual, Quality Management, Proficiency Testing Guidelines, QM004
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Appendix A: Proficiency Test Procedure
laboratory system will minimize the risk of reoccurrence and potentially improve the quality of patient results.
A performance improvement plan should be implemented to prevent the same failure in the future.
• Documentation:
The investigation, conclusions, and corrective actions should be thoroughly documented using a PTIF
(Proficiency Test Investigation Form) See Appendix D. The completed PTIF must be submitted to the CQI
office w/in a two week period. Extensions may be granted upon request (up to 30 days from PTIF issued date).
Note: If a laboratory discontinues a test, it is the laboratory’s responsibility to ensure that both the
CAP Activity Menu and the CMS regulatory reporting settings are accurately maintained. This information
must be conveyed promptly to the CQI office. Failure to do so may result in receiving unsatisfactory PT
scores from the proficiency program.

• Cease Patient Testing for repeat failures- If a laboratory is instructed to cease patient testing for unsuccessful
PT for an analyte, laboratory records must demonstrate that no patient results were released until after the
laboratory received approval from the CAP to resume testing.

G. Acceptable PT showing trending/bias: Analyzing proficiency testing results over time can reveal problems before
having proficiency test failures. Laboratory personnel must initiate an investigation and, if necessary, develop a corrective
action, in order to prevent proficiency testing failure, and possibly lead to an adverse patient event.
See CAP website: Troubleshooting guide for proficiency testing

H. Proficiency Testing Evaluation by the CQI Office:

The Pathology CQI Office screens all consultant copies of PT evaluation reports. Notices highlighting QA review
information are sent to the laboratory when necessary.
The CQI staff will review each report for:
- any analyte result with trends, with SDI +/-2.0 or greater
- certain evaluation codes given by the PT program
- lab responses for un-graded and educational challenges that do not match the peer group response
- any analyte result with a SDI +/- 3.0 or greater
- any flagged unacceptable response.
- any results that would be flagged by accrediting and licensing organizations who receive copies of the survey evaluation.
The severity of the unacceptable PT survey result will determine the type of communication the laboratory will receive
from the CQI office.
FYI: (for your information only): Sent electronically to alert the laboratory of possible testing problems. Does not
require a formal investigation, but a brief response to the alert.
PTIF: (Proficiency Testing Investigation Form) Forwarded electronically, requires a formal response with proper
investigation and documentation.

I. PT Response Requirements:
1. Each PT requires corrective action documentation for :
- incorrect responses
- failure to submit results by PT submission deadline/or improperly completed forms
- PT results omissions
- ungraded/educational results
- transcription errors.
2. If an investigation is requested by regulatory or accrediting bodies, written corrective action summaries may
be required for submission.
3. CAP Communications:
a. The laboratory will receive a Proficiency Testing Compliance Notice (PTCN) from CAP for the following
reasons:
1. Non- enrollment : Laboratory not enrolled for the appropriate PT product, the laboratory no longer
performs the test for which it was enrolled in the program, etc.
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Appendix A: Proficiency Test Procedure
2. Non Participation : May be due to test discontinued, results not submitted on time, results not reported or
transmitted correctly etc.
3. Performance unsuccessful or unsatisfactory which requires an investigation.
4. Repeated unsuccessful PT performance of a regulated analyte.
Note: See CAP resources "Escalation Process for PT Failures": Proficiency Testing Tool Box

b. All communication is coordinated through the Pathology CQI Office.

Accreditation Review of Proficiency Testing.

During the CAP inspection, the Inspector will review each laboratory’s proficiency testing enrollment, participation and
performance for regulated analytes, and non – regulated analytes (if applicable).
The inspection will include the following review:

• Verification that the laboratory is properly enrolled in an approved PT program.

• Verification that the laboratory’s proficiency test performance is satisfactory and successful for each specialty and sub-
specialty, analyte, or test.
• The retention of the following documents for at least two years: Records of test handling, preparation, processing,
examination, and results reporting.
• Physically signed attestation statement provided by the proficiency program.
• Evidence that the laboratory has documented problems or potential problems and remedial action taken when indicated.
• Evidence that the laboratory has documented review of each report by the laboratory director or appropriate designee.
• To facilitate this review, each laboratory should have its records organized and ready at the time of the inspection.
General Guidelines Manual, Quality Management, Proficiency Testing Guidelines, QM004
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Appendix A: Proficiency Test Procedure

Table #1 Common Causes of Unacceptable Results

Methodological Problems Clerical Errors
SOP problems (non- written, inadequate, Transcription error
incomplete, or incorrectly described, or outdated) Transposition error
Instrument problem identified repaired or replaced. PT sample mislabeled
Faulty standard or other reagent Incorrect reporting code selected
Calibration problems Incorrect instrument or method reported
Problem with test method validation / verification
Other method problem
Equipment problems Problems with PT Materials
Obstruction of Instrument tubing, misalignment of probe Hemolyzed specimen
Problems with instrument data processing function Bacterial contamination
Problem with manufacture reagents or reference material Poor growth in culture
Equipment malfunction Unstable PT material
Equipment software application problem Matrix effect incompatible with method
Instrument maintenance not performed appropriately Acceptable range too low
Late shipment
Technical Problems No explanation after investigation
Incorrect reconstitution of PT material, Use this choice only when a thorough investigation
reference material, or reagents. has yielded no satisfactory explanation.
Failure to follow SOP and / or PT instruction
Misinterpretation/misidentification
Dilution error or incorrect pipetting
Time delay between reconstitution and analysis
Calculation error
Run accepted in nonlinear range
Run accepted even though controls were out of range
Sample mix-up
Other technical problem