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Barry Craig, MLT (NCA), CLS
I am working on a homework assignment for my college course. We use an LW Electronics, Inc. centrifuge in our Clinical Laboratory course. The question: What calibration service intervals are recommended?
For the centrifuge, the recommended interval is six months or as outlined by the manufacturer if more frequent. The tachometer speed and also the timer should be checked every six months. The inside of the centrifuge should be cleaned as needed.
We collect blood for genetic testing and send it to a specialty lab for analysis.
Do we need to get a CLIA certificate?
The official answer is: Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. As long as your office does not perform ANY testing, you do not need a certificate. If your office performs even one urine pregnancy test, or dipstick urine test, or any test, you're required to obtain a laboratory license.
Some will say, "But we do not bill for the testing!" That is like being seventeen, drinking beer and saying "But I don't swallow it!"
One test, one CLIA certificate. Besides, the Certificate of Waiver averages out to $75.00 a year and has minimal requirements for compliance. Your patients are worth doing things right.
My lab has three employees that perform testing. Two are full time and one is part time. We were cited on a recent inspection because the part time employee did not participate in the Proficiency Testing.
I thought that only applied to full time employees?
Anyone who is listed as trained to perform testing is required to participate in the Proficiency Testing as well as the quality control testing. I see office labs all the time that will have 15 people listed as doing lab work. When you talk to them, only about six actually do the testing and the rest are "backups" and may only perform testing once a year.
It would be better to eliminate the ones who test infrequently, and stick with a primary group. Even infrequent testers are required to have their competency checked annually, participate in PT and QC testing, and meet any additional guidelines such as Continuing Education, if required. Besides would you really want your lab work performed by someone who hasn't touched the analyzer in a year? Not me!
My office has a glucose meter that FDA cleared for home use. We bill a standard code for glucose testing.
Is their a more definitive way to test for glucose?
Glucose meters that are FDA cleared for home use are considered screening instruments and do not give a definitive result or confirmed result. The only glucose meter that I am aware of that is not a screening device is the HemoCue 201. It gives a definitive glucose result and is not an FDA cleared device for home use. It also has a different billing code that reimburses at a different rate.
Chemistry analyzers that run glucose as part of a panel, or as single tests, also have a different billing code. We have a lab inspection coming up in about a week. My records are a mess and I don't know what to do. We have had a lot of employee turnover and the personnel's training has been sparse. No employee should be allowed to begin patient testing until proper documentation of training and competency has been established.
This is like one of the ten commandments of the laboratory. That and low wages, but I digress.
Proper recordkeeping of QC, personnel training, maintenance, etc. should be a continuous ongoing effort. If your records are a mess, you do not have a proper Quality Assessment plan in place. QA looks at all the components of what happens in the lab before testing, during testing, and after testing takes place. I would contact a Laboratory Consultant and have them come in to revamp your whole system.
They also can aid in helping you with your Plan of Corrective Action after your inspection. The best time to utilize a Lab Consultant is before there are problems.
If you work in a physician office lab, the best advice I can give you is this: Let a professional come in and look at your entire system. A fresh set of eyes can point out coding problems, testing problems, documentation problems, etc. It is an investment that will pay off with better patient care and better inspections.
If anyone has lab related questions, or any really good (or bad) southern jokes, you can contact me through my website at: www.OnlineLabHelp.com.
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