Proficiency Testing (PT)

Proficiency testing is an external check that monitors the quality of test results produced by this lab. It is a form of “blind testing” that helps this lab and the regulating organizations verify that the test results produced by this lab are accurate.

The following waived tests performed in this lab do not require PT or split sample testing:

INRatio

Flu Swabs

Throat cultures

The following non-regulated analytes require PT or split sample testing participation:

PSA

The following regulated analytes require PT participation:

ACR Creatinine

ACR Albumin

HbA1c

Albumin

Alkaline Phosphotase

AST

ALT

BUN

Bilirubin, Total

Calcium

Cholesterol

CO2

Creatinine

Glucose

HDL

Phosphorus

Magnesium

Protein

Triglycerides

Uric Acid

TIBC

This lab has chosen American Proficiency Institute (API) as the provider for our proficiency testing.

They can be contacted at:

American Proficiency Institute

1159 Business Park Drive

Traverse City, MI 49686

Performance of Proficiency Testing

Documentation requirements include recording the handling, preparation, and testing of the PT samples. This includes:

  1. A copy of the instructions that came with the samples
  2. A copy of all the worksheets and instruments printouts of the testing
  3. The PT enrollment form
  4. A copy of the result submission form used as practice
  5. A copy of the final completed result form sent to the PT provider, including the signed attestation statement.
  6. The reviewed PT score report including the CMS summary page.
  7. Documentation of investigations and corrective actions for any PT failures.
  8. Documentation of any needed self-evaluations that were performed.
  9. Copies of the documentation will be retained a minimum of two years.

When the PT testing shipment arrives the testing personnel will proceed in the following manner:

  1. Inspect the kit to confirm that the item that arrived is what was ordered, and that samples were not missing, nor damaged or broken during shipment.
  2. If any part of the shipment is damaged, testing personnel will contact the American Proficiency Institute immediately for replacements for damaged or missing samples.
  3. Document the date the shipment was received and note the date that the results are due on the calendar. This normally is no more than 10 days.
  4. Store the shipment or kit as instructed by the information contained in the shipment.

When preparing for the proficiency testing, follow the accompanying instructions closely. There can be no deviation from the procedure. Pay attention to time limitations on the stability of the sample. All PT samples should be considered potentially infectious or hazardous, and should always be handled using Standard (Universal) Precautions.

Proficiency testing must be performed in the same manner as routine patient specimens.

  1. Use routine testing methods
  2. Staff that routinely tests patients will also test PT samples. Performance of PT testing will be rotated through testing personnel in throughout the year. A schedule will be establishing this rotation will be at the beginning of each year.
  3. No repeat testing and averaging of results is permitted.
  4. Keep any leftover PT samples. These can be frozen for use in retesting and evaluating failed PT scores.
  5. Any samples that cannot be retained should be discarded in the biohazardous waste.
  6. Complete the result submission form. Pay attention to detail – avoid transposed numbers, decimal points in the wrong place, entering a result for the wrong sample in the designated space, entering results in the wrong units.
  • Enter the instrument or method code form each test performed
  • Enter all information requested on the test result form
  1. Have a second testing personnel review the completed form for correctness before submitting.
  2. Make sure the testing person and lab director sign the attestation statement.

Review of Proficiency Testing Reports

All proficiency testing scores will be reviewed within one week of receipt. This includes reviewing the report and confirming:

  1. The CLIA ID# is correct
  2. All tests for which results were submitted received a score.
  3. Compare the results with the copy of the reporting form retained before submission.
  4. Copies were sent to all agencies and consults that were requested.
  5. Test methods indicated are correct.

All analytes which demonstrated satisfactory performance will be evaluated by the testing personnel and lab director and analyzed to see if:

  1. All analytes are on the same side of the mean
  2. If there are any Standard Deviation that are greater than 2.0
  3. If there are any patterns to the results that could indicated a developing problem
  4. If any results not graded

These will be discussed at the regularly scheduled lab personnel meeting. The lab director will then initial the report indicating a review was performed. This will be retained with PT paperwork associated with this testing event for two years.

If any PT results were not graded, then a self-evaluation of the results will be performed. A self-evaluation may also be performed if there was a failure due to clerical error or late return of results as detected above. This will be initiated immediately by testing personnel in conjunction with the lab director. This may require special or additional lab meetings.

If there are any analytes which have been shown to have an unsatisfactory performance for a testing event, the following evaluation will be initiated by testing personnel in conjunction with the lab director. This may require special or additional lab meeting.

  1. Determine if the abnormal results are noted on more than one test for that instrument. This may indicate an instrument related problem requiring investigation.
  2. Determine in the problem is only affecting test results in a certain range (above or below the mean). This may indicate a linearity or calibration problem.
  3. Determine if there is a problem with several different analytes from the same PT specimen. This may indicate a problem with PT specimen integrity or reconstitution.
  4. Evaluate the status of the affected test at the time of the initial testing and determine if maintenance had been performed appropriately.
  5. Evaluate quality control logs and ensure all were in range, or if starting to trend or shift.
  6. Determine the time of the last calibration.
  7. Evaluate temperature logs.
  8. Check to see if all reagents and/or controls are in date.
  9. Retest theoriginal PT specimens that were retained as above:

If results of the original sample in question are now in range: / If two or more results for the original sample in question are biased in the same direction: / If results of original PT sample retest are NOT in range:
Problem will be termed “random analytic error” as a result of:
  • Aliquot evaporation
  • Pipetting error/dilution error
  • Instrument instability / power surge
/ Problem is referred to as “short term systematic analytic error” that may have been due to:
  • Improper instrument maintenance
  • Reagent deterioration
  • Improper calibration
/ A new sample of the PT material in question will be obtained from American Proficiency Institute and be tested. If a sample of the PT material is not available, then split-specimen testing may be performed.
If the new specimens are now in range, then the problem may have been due to:
  • Bacterial or fungal contamination
  • Delay or temperature damage in shipment
  • Hemolysis of specimen
  • Reconstitution error or delay in testing
/ If the results of new specimens are out of range, the problem is likely due to “long term systematic error” such as:
  • Miscalibration
  • Repetitive procedural error
  • Infrequent performance of the test
  • Major instrument maintenance problem
  • Matrix effect / incompatibility with this lab test method

Miscalibration: recalibrate the instrument
Repetitive procedural error: reevaluate procedure and staff retraining
Infrequent performance: staff retraining or consider stopping testing for that analyte
Major Instrument Maintenance problem: call for service
Matrix effect / incompatibility with lab method: call American Proficiency Institute
If any of the above problems are identified by the above solution, then an evaluation of patient results since the original proficiency testing occurred will be performed, including:
  • Special and additional lab meetings
  • Review of daily patient logs for trends or patterns of abnormal lab results
  • Review of testing personnel logs vs abnormal results to look for trends by personnel
  • Documentation of investigations and corrective actions for any PT failures.
  • Documentation of any needed self-evaluations that were performed.
  • Copies of the documentation will be retained a minimum of two years.

Proficiency Testing Documentation

Date and time PT kit arrived:
Date results are due to be reported:
Kit inspected
Are these the samples which were ordered?
Is there any damage to the samples?
Kit stored according to instructions?
Copy of kit instructions attached to this form?