| Monday, January 01, 0001
A:The Lead Care 2 is the only device I am aware of that can be used in the physician office for lead testing that is in the Waived category. You would have to have a Certificate of Waiver to use it, but Proficiency Testing would not be required. If your state has regulations requiring submission of your results, you would need to contact the Department of Public Health for your state to learn what is required to be submitted.
Q:How does our highly complex lab become a Blue Plus lab? I was told that our lab could perform more lab testing if Blue Cross recognized us as a Blue Plus lab and not just a POL.
A:You need to contact the Credentialing Coordinator at Blue Cross. They have a 1-2 page application for Blue Cross Plus lab. Fill it out and PRESTO! They will send you verification of your new status in about two weeks.
Q:Our lab had a recent inspection by CLIA and they cited us for the "environmental conditions" in our lab. They said temperature, humidity and storage conditions were not met. How do we fix this?
A:Any automated lab instrument that is plugged into a wall has the operating conditions listed in the owner's manual. These usually include the temperature range and humidity range that the machine will operate under and the parameters for space, power needs, etc. CLIA says that if an instrument manufacturer specifies a range of temperature or humidity that the instrument must operate under, then that must be monitored. Also different supplies or consumables for that machine may not all store at room temperature. You have to read the insert for each item to determine its storage needs or look at the side of the box.
In general the lab area:
- Should be well lit. The lab should have excellent lighting to better facilitate the testing taking place.
- Should not have windows that allow sunlight to directly hit anything. Sunlight can increase the temperature, cause UV harm to your instruments, and cause improper storage conditions for supplies.
- Should have adequate HVAC in place. Proper venting for heating and cooling is essential to maintaining a proper temperature range
- Should not be a pass through area. The lab should not be a traffic area where patients and employees regularly pass through. It should have only one door, clearly marked, as the lab area.
Q:Is eating and drinking in the lab completely off the table? (pardon the pun) Our lab has an area at one end that has the desk setup with the computer. We do not perform any lab testing in this area and keep our purses, jackets, etc. here. Could we not keep snacks in this area?
A:No food, drink or cosmetics should be in the lab. This would indicate no eating, drinking or application of cosmetics should take place within the lab. I have been a part of over 250 lab inspections and, without fail, if the inspector found any evidence of the above mentioned items, the lab was cited with a Conditional Deficiency (the most severe). I know an inspector that found a single peanut loose in a drawer and still cited them for it. He said, and I quote, "Where there is one peanut, there were more because you can't eat just one!"
Don't do it, plain and simple. One peanut to an inspector is the same as if you set up an "all can eat" buffet next to your instrument. Which is a funny mental picture, but not a good idea.
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.