Ask The Expert

My doctor wants to perform a serum creatinine test on our patients. Our instrument only runs a creatinine on urine. Can I just use the machine and run the assay on serum?

No, no, no. If you perform any test differently than the manufacturer intended, your lab automatically reverts to High Complexity. This means that your lab then has to meet a phonebook’s worth of extended regulations and new requirements including running extensive studies to change the test methodology.

This also applies to simple Waived tests such as a rapid Strep A.  The manufacturer states that the specimen for testing is a throat swab. Some pediatric offices sometimes want to test a rectal swab for Strep A. This is outside of the scope of the manufacturer’s recommendations so testing a rectal swab would work magic. Presto! You’re a High Complexity Lab! You then would be held to the High Complexity rules. I have seen it happen first hand on an inspection and it is not pretty.

I am not happy with the company we use for Proficiency Testing. We have only been with them for one event but I want to go back to my old company. Is this allowed?

Choosing a PT company is like a short-term marriage. You have to stick with one company at least a year before you are allowed to switch to another.

You can evaluate PT companies by talking to other offices who use them, looking at the size of the peer groups for the test you perform, and ask the company directly for information. Cost should not always be the only consideration for selection. Make sure the PT offers testing for all the tests you need PT for. The test menu for PT companies varies and not all PT companies carry the same testing selection.

Once you determine that two or more PT companies have the test menu you need, then kick the tires, ask questions and let the companies know you are shopping. Some will offer discounts on the spot to gain your business.

My office has a microscope and the doctor looks at urine sediment slides. We have a PPMP certificate and that is the only microscopic test we perform. Do we have to do any skills assessment for the doctor?

Yes. Having MD behind your name does not exempt you from competency assessment requirements when you perform testing. The easiest way to achieve this is to sign up for Microscopy with a PT provider. They will send microscopic photo challenges three times a year for the doctor to identify. The challenges even have a short patient history to aid in reading the photos.

It is fairly inexpensive and is an easy way to show competency in performing the microscopic procedure.

We are getting ready to open a new pediatric office. What are some of the most common test that pediatric offices perform in-house?

Glad you ask! I worked exclusively with pediatric offices for years and here is the best list:

Waived Testing:

1. Rapid Strep A

2. Rapid Mono

3. Rapid Influenza A&B

4. Urine Pregnancy test

5. Urinalysis

6. Hemoglobin/Hematocrit

Non-Waived Testing:

1. CBC (Complete Blood Count)

2. Neonatal Bilirubin

3. Mycoplasma

We are starting a new, Non-Waived lab in an Internal Medicine practice. What does the doctor have to do to be Lab Director? What else has to be done?

If the physician has never directed a Non-Waived lab, is not a pathologist, and does not have at least a year of pathology training, they must complete a 20 CME Lab Director Course to qualify. The course is offered in an online format or, they can attend a three day seminar to complete it. Go to www.cola.org to learn more.

Completing the course will qualify them as Lab Director. They also qualify as Clinical Consultant, which means they can diagnose and treat patients using the results. However, for the first year of operation they do not qualify for Technical Consultant. This is a required role for the Non-Waived lab and is one of the most frequently cited problems on an inspection.

The Technical Consultant role oversees the technical aspects of the lab. They monitor the instrumentation, the QA program and the QC program.

This position can be filled by an outside consultant for the first year of operation and longer, if desired. They do not have to be onsite to fill the role, but they must have the proper credentials and be qualified. My company has filled this role for many offices. The office usually will send in monthly data and information for review and the Technical Consultant will generate a report for retention for inspection purposes.