Ask The Expert

My hematology instrument is supposed to operate between 20% and 80% humidity. The winter weather has our heat running a lot and the air is drying out. Our humidity levels are nearly down to 20% now. Help!

Winter weather dries out everything. Air, people, and my checking account when I get the power bill.

You really have two options when it comes to this problem:

1. Close off the heat vent in the lab that is blowing the dry, heated air

2. Purchase a cool mist humidifier and run it in close proximity to the instrument.

Always keep your temperature/humidity monitor close to the instrument itself. If your instrument is at one end of the lab and the monitor is at the other, move the monitor closer to the instrument. The humidity may not be as low where the instrument is located.

Since you can’t moisturize the instrument by applying lotion, these are probably your best options.

Someone called the other day offering generic reagents for my analyzer. Will this void my warranty if I use them? Should I use them at all?

Generic anything usually will save you money and, by law, the manufacturer cannot void your warranty if you use supplies other than theirs.

Now to the question of “Should I use generics?” I think generic substitutes are fine for antacids and bandages but I would not recommend them for reagents.

Typically they do not have the stability and performance consistency of the brand name reagents. The manufacturer’s reagents, controls and calibrators are specifically designed and produced for that instrument. You pay a lot for the instrument and you probably should stick with the manufacturer’s stuff.

After all, if you had a Ferrari, you would probably not take it to Walmart to have the oil changed.

(I would settle for a Porshe)

My Lab Director took the online course to get his 20 hours CME to qualify as Lab Director for Non-waived testing. Will he have to update this at some point or do any follow ups?

Nope, once it is complete, it is complete. The course work qualifies the physician to be a Lab Director of a Non-waived lab. However, it does not qualify him for the required role of Technical Consultant. He has to be in the position of Lab Director for a full year before he will qualify to take over this position.

Here are the qualifications for Lab Director according to the CLIA Bible (The Federal Register)

LABORATORY DIRECTOR – Must be a doctor of medicine (MD) or doctor of osteopathy (DO) or doctor of podiatric medicine (DPM) and meet one of the following:

Option 1:

Be board certified in Anatomic or Clinical Pathology by the American Board of Pathology or the American Osteopathic Board of Pathology, or be board eligible;

or

Option 2:

Have laboratory training or experience consisting of at least one year directing or supervising non-waived laboratory testing;

or

Option 3:

Have at least 20 continuing medical education (CME) credit hours in laboratory practice commensurate with the director responsibilities. A list of ACCME-accredited providers can be accessed via the Internet at http://www.cms.hhs.gov/clia;

or

Option 4:

Have laboratory training during medical residency equivalent to 20 CMEs;

or

If not a MD, DO, or DPM and employed in a physician office laboratory:

Option 5:

Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology;

or

Option 6:

Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and have at least one year experience directing or supervising non-waived laboratory testing;

 or

Option 7:

Hold an earned master’s degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; have at least one year of laboratory training or experience, or both in non-waived testing; and have at least one year of supervisory laboratory experience in non-waived testing;

or

Option 8:

Hold an earned bachelor’s degree in chemical, physical, or biological science or medical technology from an accredited institution; have at least two years of laboratory training or experience, or both in non-waived testing; and have at least two years of supervisory laboratory experience in non-waived testing.