Ask The Expert With Barry Craig | October 2013

Q: What is best way to keep up with expiration dates for reagents, controls, and other materials?

A: I suggest making an Excel database for all items you currently use. You can set it up to change colors when an item listed reaches its expiration date. Another method you can use is a shelf system. Put newly received items on a lower shelf and mark them with the received date. Put items in use on a higher shelf and date them with an opened date and open expiration date. What is an open expiration date, you ask? Glad you are so full of questions! The open expiration date is the date that a product expires once opened. Most reagents, controls, and calibrators are good until the date printed on the label as long they are not opened. Once opened, the expiration date is usually shortened to 30 or 60 days.

Q: Who is responsible for performing the competency assessment?

A: The Technical Consultant (TC) for moderate complexity testing is responsible for performing and documenting competency assessments. The competency assessments may also be performed by other personnel who meet the regulatory qualification requirements for TC for moderate complexity testing.

The Technical Supervisor (TS) for high complexity testing is responsible for performing and documenting competency assessments. This responsibility can be delegated, in writing, to a General Supervisor (GS) as long as the GS meets the regulatory qualifications as a GS for high complexity testing.

Testing personnel who do not meet the regulatory qualifications of a TC, TS, or GS cannot be designated to perform competency assessments. This means that personnel cannot perform competencies on each other unless they meet the CLIA standards.

Ultimately, the LD is responsible to ensure that all testing personnel are competent and maintain their competency in order to perform and report accurate and reliable test results.

Evaluating and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual tests patient specimens. Thereafter, competency assessment must be performed at least annually. Competency assessment can be done throughout the entire year by coordinating it with proficiency testing events, training new employees, error log and problem log resolutions, etc. These things can be used as part of competency assessment.

Q: How am I supposed to test my PT samples? Any differently than I test patient specimens?

A: PT samples must be tested in the same manner you test patient specimens. This means testing the PT samples the same number of times as patient specimens, at the same time as patient specimens, by the same personnel that routinely test the patient specimens, and using the same test system that is routinely used for the patient specimens. PT samples should be rotated among the testing personnel in your laboratory. Please note that some PT sample preparation may be necessary before testing. In other words, after preparation, PT samples must be treated in the same manner as patient specimens. However, NEVER send PT samples out of your laboratory for any reason, even if you routinely send out patient specimens for additional or confi¬rmatory testing.

Barry Craig


Expert on physician office laboratories and diagnostic equipment

Barry works almost exclusively with POLs and understands the needs and challenges they face. With more than 20 years of lab consulting experience, his company works with office lab start-ups, inspection follow-ups, and help with the CLIA, COLA and JCAHO regulatory issues offices face daily. He offers a unique insight and customer focused approach to the lab and its solutions. In his current role as President of Laboratory Consulting, LLC, Barry is leading the way for physician's offices to develop their in-house labs as a place to obtain fast, accurate results and maintain a healthy profit using the latest technology available.

Being in touch with the POL community nationwide his company has a unique insight into the problems and questions that arise from the operation of a POL.