Ask The Expert With Barry Craig | September 2012

 

Q:

The chemistry instrument we have uses DI water. We have a unit that creates it and filters it. The doctor wants to stop using this device and get water in gallon jugs from the supermarket. He says it is the same thing. Does this really matter for the instrument?

 

 

A:

Yes, it actually matters a lot. Deionized Water or "DI water"  is just what it sounds like: Water that has the ions removed. Tap water is usually full of ions from the soil (Na+, Ca2+), from the pipes (Fe2+, Cu2+), and other sources. Even water by the gallon, unless it is specifically deionized water, can have impurities in it.

 

When you are using a chemistry analyzer, the ions in water can cause interference. They can switch places with other ions you may be interested in finding. An example is calcium. If the water you are using has a lot of calcium ions in it, it could give you false results for calcium on your instrument. Also water with ions in it is also quite a lot more electrically conductive than water without ions in it. This could cause electrical impedance fluctuations. I would stick with what you have now and avoid the potential problems. 

 

Q:

I do not know a lot about the laboratory. I basically inherited this physician office lab when the previous employee left. Are there any good resources I can access online to learn more?

 

 

A:

Yes, yes, yes! I am always glad to hear from someone who wants to learn more and do things right.

 

www.cola.org has excellent resources for education and information about laboratory testing. They also hold twice yearly symposiums where you can go for a three day learning experience. You pick the classes that interest you and learn from the best in the industry. (It is also a lot of fun! They feed you well) A symposium is coming up in October in Baltimore, details are on the website.

www.westgard.com is an excellent resource for the technical aspects of the lab. It is a great resource for learning about quality control and calibration.

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/ is the government website for all things related to the CLIA regulations. It actually has some great resources for learning about lab. Yes, your tax dollars actually got spent in a useful manner. (the shock is overwhelming)

 

Q:

Our clinic draws blood and sends it to a reference lab for testing. We do a urine pregnancy test about once every two months. Does our clinic have to have a CLIA certificate?

 

 

A:

Yes, I am afraid so. Even if you perform only one test a year, you must get licensed. However, a Certificate of Waiver is only 75.00 a year (150.00 every two years). This is a small price to pay to be able to perform the tests that you need at the frequency you need them done. Just follow manufacturer's uidelines and document training for the test. Check with your state CLIA ofice to make sure there are no additional state regulations.

 

 

Q:

If we scan the original printout from our instrument into the patient record, do we have to eep the paper copy? The instrument also retains a copy in an electronic format.

 

 

A:

The CLIA regulations state that all original printouts must be retained for two years. A scanned original meets this requirement. You do not need to
retain the paper printout. Always make sure the scanned copy is accessible and retrievable for inspection purposes.

 

 

 

 

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.

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