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CRI Lab Quality Advisor

Proficiency Testing Proficiency

Published December 5, 2013 3:33 PM by Irwin Rothenberg
Proficiency Testing is an important part of any laboratory quality assessment program.  It is an external assessment of your staff's performance  by facilitating  the comparison of your laboratory's test results with other laboratories using the same instruments or kits, and methodology.  While we have discussed proficiency testing before, in the context of competency assessment, today we will focus on the process and requirements of proficiency testing itself.

Once  you receive your specimens from your PT provider,  you  must follow the same procedures for the storage and handling of these specimens that you would for any patient specimen received by your laboratory. This is a must if you are to get the maximum value from these programs. In effect, think of PT specimens simply as additional patient specimens and treat these accordingly. This rule applies through all phases of testing: pre-analytical, analytical and post-analytical. True, you are not "drawing" or "collecting" these specimens directly from the patient, but receiving them is only one step removed.

All staff who normally perform this testing, even if only occasionally, should participate at some point during the year.  

These specimens should be treated in exactly the same manner as all other specimens; that is, if your routine is to test the specimen once on your instrument or with your kit reagents, then the same holds true for PT specimens. If on the other hand, you would rerun abnormal results to verify the efficacy of the result, then by all means do so for your PT specimen as well. Do not have several staff run these specimens and pool the results before reporting them. If you treat these specimens in a "special" manner, then what are you achieving?

It is a good idea to save "left over" samples when possible, so if you need to recheck your results after your results are graded, you will be able to do so easily.

Remember: NEVER, NEVER, share your results with another laboratory, even a "sister" laboratory, until your results are sent off, and the official window of time for accepting specimen results by the provider, has closed.

Record keeping and documentation are of high importance, as there are specific requirements by CLIA and/or your accreditation organization: Your files should include:

  • Original instrument tapes,  as well as worksheets, if using kits.
  • Signed Attestation forms by your LD or qualified designee, as well as testing staff involved; 
  • Copies of your result forms submitted for grading or sent in electronically; 
  • Graded results received with documentation of review by Lab Director or qualified designee;
  • Documentation of corrective actions taken if there is an unsatisfactory or unsuccessful results

When you follow both the spirit and the letter of the regulations for handling Proficiency Testing, treating it as a valuable  quality indicator, then you will truly be proficient in how you are using PT.


A good first step with proficiency testing is checking the paperwork to make sure the specimens are intended for testing under the proper CLIA number.  In systems with multiple CLIA's / locations, it is extremely important to make sure PT specimens were not delivered to an incorrect location; if testing personnel do not check for this and testing is performed, this could be construed as "referring proficiency testing" (however unintentionally it might have occurred) since the proficiency testing is assigned, specific to each CLIA.  

Jodie, Healthcare - Director of Laboratory Services, Sarah Bush Lincoln Health Center December 13, 2013 2:38 PM
Mattoon IL

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