Ask the Expert

Hello Good Readers!

Today we are going to focus on Waived Testing. These are supposed to be the simple tests that anybody can do and if done incorrectly, would not cause harm to the patient.

Waived laboratories must meet only the following requirements under CLIA:

  • Enroll in the CLIA program;
  • Pay applicable certificate fees biennially
  • Follow manufacturers' test instructions.

The types of tests waived under CLIA have increased from 8 to approximately 100 tests since the inception of the program in 1992. Because of the few requirements for testing, the number of laboratories issued a Certificate of Waiver has grown from 20% to 69% of the approximate total of the 236,000 laboratories enrolled. That means over 162,000 labs perform only Waived testing. This does not include the higher level of labs that perform Waived testing as well.

There is a report everyone performing Waived testing should read. It is called Good Laboratory Practices for Waived Testing Sites. It is a government report and can be found here: http://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf

This report shows the findings when the government inspected just a sampling of Waived sites.

Remember, all they are required to do is follow manufacturer’s instructions for performing the testing.

The report found:

  • 12% of labs did not have the manufacturer’s package inserts or instructions

  • 21% did not routinely check for changes to the instructions or package insert

  • 45% did not perform required quality control or document it

 

This means 1 in 10 labs did not even have the instructions to perform the test. It means that almost half the labs did not perform the controls to make sure the test was working properly.

 

There are many more findings in the report, but these are some of the most disturbing. So, what is the answer? What can be done to insure good results are being turned over to physicians?

 

 

 

Several simple steps can be taken:

 

1. Make sure the employees running the Waived testing have been trained and are competent. Have the manufacturer’s rep train them or someone who is well versed in the testing do the training and document it.

2. Run the controls at the frequency recommended by the manufacturer. Make sure they are working properly and document them.

3. Before the testing takes place, make sure the employees are identifying the patient properly, labeling the tubes, swabs, etc. used in testing, and working from a written test order.

4. Generate a written test report to give to the ordering physician. NO VERBAL RESULTS.

 

This is by no means comprehensive, and the government report goes into a lot more detail with many more recommendations.

 

For more information on Waived testing you can also go to www.cms.gov