Laboratory Quality Assurance (LQA)

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FAQ: What is proficiency testing and why must I enroll?
Proficiency testing (PT), mandated by CLIA '88, is a source of external quality control. This practice of testing unknown specimens from an outside source provides an additional means to assure quality laboratory testing results. Although laboratories perform daily internal quality control with their test systems, external quality control provides important interlaboratory comparisons to determine the accuracy and reliability of the testing procedures.

For laboratories applying for an initial Medical Test Site (MTS) license (non-waived or non-PPMP categories), proof of enrollment in an approved PT program must be submitted to LQA before the MTS license can be issued.

FAQ: When do I enroll?
If you are currently enrolled in proficiency testing, the time to renew for the following year is between October and December. New laboratories must enroll in proficiency testing to cover its regulated analytes (tests) at the time of application for the MTS license. Proof of enrollment must be submitted to LQA before an MTS license will be issued.

FAQ: What programs are approved providers for proficiency testing?
A listing of the currently approved PT programs and their phone numbers can be found by clicking on Approved PT Providers. Call for a free copy of their PT brochure. If a laboratory is currently enrolled in PT, the PT provider will automatically send a PT renewal order form and catalog for the following year. Remember, if a laboratory does not enroll quickly it will not be guaranteed to receive samples for the first testing event that occurs between January-March and will receive 0% for non-participation. This is a failure, and may jeopardize the ability to continue to perform testing.

FAQ: How easy is it for me to enroll?
Very easy! Just complete the Order Form in the PT brochure which asks for your name (use the NAME exactly as it appears on the MTS license, no other name accepted), address, CLIA ID Number and laboratory MTS license number (see MTS license), and select the appropriate program for the laboratory. Remember to indicate on the order form that a copy of the PT results be sent to the Office of Laboratory Quality Assurance.

FAQ: What program must I enroll in?
A laboratory must enroll for those programs that cover the testing that is performed. Generally, most programs are five sample modules shipped in three test events during the year. Two sample programs are available and acceptable for non-regulated analytes only. Here is an example: A laboratory is performing rapid strep antigen with a non-waived kit, serum pregnancy and complete blood count (CBC) on an instrument. These are all regulated analytes. Therefore, a five sample program must be selected for rapid strep antigen, serum pregnancy and a hematology module. (Note: Bacteriology, Mycology, Mycobacteriology: these subspecialties do not have "regulated analytes" per se. However, the laboratory must subscribe to a module that covers the testing performed.) Click on Regulated Analytes for a complete listing.

FAQ: What strategy must I take to pass PT?
The PT provider lists the shipping dates for its samples. Mark these dates on a calendar you will see! If you will not be at the laboratory when the samples arrive, give special instructions to whomever will be there to put the samples in a specific place in the refrigerator and/or perform the testing for you. If the sample does not arrive around the shipping date, IMMEDIATELY call the PT company’s 800 number.

When you test the PT samples, follow the directions exactly as provided by the company. If the samples test "weird", immediately call the 800 number for assistance. Otherwise fill out the answer sheet COMPLETELY, listing the method, kit, reagent, etc. Your results will not be evaluated if your answer sheet is incomplete. Sign the Attestation Statement (Laboratory Director and Testing Personnel). Make a copy and put into the mail by the due date. If your mail system is unreliable, send it certified. Some of the PT companies will allow you to fax results.

When you receive your graded results, review the results with your laboratory director. If you receive a score of 60% or less (80% is passing for most analytes), you must investigate why you failed and document your plan of correction.

If you receive results that are not graded, call the 800 number for assistance. The PT provider will review the results with you. Under the Quality Assurance rule you must manually evaluate ungraded PT results.

FAQ: What must I do if I add a new test?
You must notify our office immediately and, if this new test is a regulated analyte, you must cover the test in the next PT event. When you notify us, we will remind you to enroll in PT and ask you for proof of enrollment.

FAQ: What if I decide to stop testing an analyte?
You must notify our office immediately that you have stopped testing. If you have signed up for PT for this analyte, be sure to choose the code "test not performed" on the answer sheet.

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Last Update : 05/21/2009 06:40 PM
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