Ask The Expert

We received a scary letter from CLIA regarding proficiency testing. Should we be concerned?

The letter from CLIA went out nationwide regarding rules of Proficiency Testing. CLIA has cracked down on PT referral and other forbidden practices related to PT.

Here are the highlights and some additional advice:

If you send a PT sample out to another lab for analysis. or discuss your results with another lab before submitting the results and are caught, the penalties are: 1. Immediate revocation of the laboratory’s CLIA certificate for one year

2. Immediate loss of Medicare/Medicaid payment

3. The inability of the owners/operators of the laboratory to own/operate any laboratory for 2 years.

Isn’t that delightful? CLIA is no longer showing any mercy regarding PT trickery. Many CLIA appeals are related to PT referral and in every instance CLIA’s findings and penalties has been sustained.

CLIA requires labs that receive what appears to be a PT sample from another lab to notify the CMS about it, and the agency has received 'a good number' of such reports of late.

CMS prepared a letter to be sent to laboratory directors listing the do's and don'ts related to handling PT samples, and the agency will place this information on the CMS/CLIA Web site at www. cms. hhs. gov/ clia. Says Judy Yost (Director of CLIA): 'We really do not want labs to get caught in a circumstance where a silly accident happens and they are in a place where they can't really go back.'

Yost believes education can help solve the problem of PT referral. It's a matter, she says, of making sure new staff are aware of the implications of PT referral, and having good policies and procedures and the infrastructure in place to prevent it. 'The lab should have a mechanism in place to make sure the PT sample isn't mishandled. And make sure people know the sample is not to be referred even when the protocol calls for reflex testing on a patient sample.' Yost says a sample clearly labeled as PT should provide a warning so that someone who sees it knows to stop and handle 'on the spot' a situation in which a PT sample has slipped into a batch of other tubes headed to a reference laboratory.

The additional advice is this:

Make sure you have a written policy regarding PT and its handling and make double sure all personnel who perform PT have read and signed it. This covers you legally and makes the employee aware that failure to follow the policy could result in termination.

CLIA says that we have to document training for employees performing lab testing. What about temporary agency employees that are only here for one day?

What if the guy who sweeps the floor at a restaurant walked up to your table and announced “Hi, the cook is out today, so I am going to prepare your meal!”

You would probably have a few questions for the “new” chef, such as “Every set foot in a kitchen before, Gordon?”

Anyone that performs lab testing in your lab must have written documentation of training and competency to perform the tests. This would be especially important for a temporary worker. They are more likely to get confused or overwhelmed and make mistakes. Beware of “we are certified by the Agency”. This will not fly with CLIA on an inspection.

If any advanced notice is possible, bring them in for a few hours the day before and document their competency and training. They will feel more comfortable the next day and definitely make fewer mistakes. Always remember, there is a patient in that tube of blood, and they deserve a well-trained operator to perform their testing!

We are a waived lab and we are getting rejections on our CPT coding for some tests. What is the problem?

If you are a waived lab, you must use the QW modifier when you submit for billing. Any code without the QW modifier will be rejected. If you are a non-waived lab but are performing some tests by waived methods, you still must use the QW modifier on those tests.