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Waived labs should already be doing what we in the lab call “good laboratory practice.” These are basic tasks performed to ensure that all lab results are accurate, consistent and reliable. Currently CLIA only requires offices performing waived lab tests to follow the manufacturer’s instructions. The problem is, according to a recent survey, most offices are not. So any new, stricter guidelines would really be about enforcing the compliance of that requirement.


The manufacturer’s instructions are based on “good laboratory practice.” Most of the kits are tested under ideal conditions, and 510(k) approvals are based on those idyllic conditions. Manufacturers’ instructions give guidance for storage, temperature, controls, training and procedure. Each of those steps should be monitored and documented. You know the rule: If you didn’t write it down, it didn’t happen.


Here is the minimum recommended documentation that should be maintained:


1-      Date on the kit when it was received. Note the expiration date (and make sure you will use the number of tests in the kit before it expires.) Date on the box when it is opened and put into use. It’s a good practice to note also on the box that the controls were done. (See “controls” below.)

2-      Storage. Most kits can be stored at room temperature. Others need to be refrigerated. Either way the temperature of the room and refrigerator should be documented daily. Thermometers are inexpensive; place one in the fridge and one in the room close to the testing area. Develop a log to keep record. Paper or digital? Almost all offices have a computer. I prefer the digital. It’s easy to create a spreadsheet, or it can even be noted in Outlook calendar.

3-      Training. The No. 1 citation is lack of training or at least documented training. Make a training log or download from The log should include:

  • Test brand name and method.
  • A statement, signed by each testing personnel, that says they have read the procedure, feel competent to perform the test, and will follow the manufacturer’s direction without modification. This allows for any future issues with questionable results. The tech cannot say they were not properly trained.
  • Place the document in the personnel folder.
  • This training can be administered by the lab director or designee. The other option is to have the manufacturer or distributor provide training as a value-added service.


4-      Controls. One of the reasons waived kit tests are considered foolproof is that they have a built-in control for each test cartridge. But the manufacturer usually requires that a positive and negative external control be performed when the kit is opened or with each new lot number. The reason for this is shipping and storage. The manufacturer has no control over the extreme temperatures or moisture that the kits might come in contact with. Besides, it is good lab practice to double check your tools before you use them. Most kits come with the required controls. If they do not, be sure to ask where you can find external controls to meet regulations. Be sure to keep a record of the controls. The log can be paper or digital (think spreadsheet), and should include the kit lot number, expiration date, date of testing, results of the controls and the tech’s initials.


By Tim Dumas

The above guidelines will be a good start to ensure that the results the lab is putting out are reliable and consistent. It sets a standard that all testing personnel can follow with confidence. The paperwork does not take as much time as most people think, especially when it becomes habit. Feel free to give this article to your waived labs and please send questions to


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