Ask the Expert – Barry Craig

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This month we are going to explore the most common CLIA certificate in use, the Certificate of Waiver.

Certificate of Waiver

This the most common federal CLIA certificate is the Certificate of Waiver. Well over 500,000 have been issued since 1988.

As defined by CLIA, waived tests are categorized as

  • Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.

  • **Pose no reasonable risk of harm to the patient if the test is performed incorrectly
  • Are cleared by the FDA for home use.
  • Conduct testing that is considered non-technical requiring little or no difficulty.

**This description is up for debate because any test that is not performed properly can cause harm to a patient.

For a list of waived tests sorted by test name, go to the FDA website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm.

Enrollment

You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available online at www.cms.hhs.gov/clia or from your local state agency. Once you complete the application mail it to the address of the local State Agency for the State in which your laboratory is located. You may also be able to fax or email the application in, depending on your state. A list of State Agencies is available at the web site listed above. If you do not have online access and do not have information about your state agency, you may contact the CLIA program at 410-786-3531 for the address and phone number of your state agency. For some states, there are additional requirements or state forms that must be filled out as well. Check with your state agency office to see if any additional requirements must be followed.

Regulations

For waived testing, CLIA requires that you:

1. Enroll in the CLIA program by obtaining a certificate

2. Pay the certificate fee every two years (currently $150.00)

3. Follow the manufacturers’ instructions for the waived tests you are performing;

4. Notify your State Agency of any changes in ownership, name, address or director within 30 days, or if you wish to add tests that are more complex

5. Permit inspections by a CMS agent, such as a surveyor from the State Agency. However, your laboratory is not subject to a routine survey or inspection.

 

To follow the manufacturer’s instructions for performing the test means to follow all of the instructions in the product insert from “intended use” to “limitations of the procedure.” The manufacturer’s instructions can be found in the product insert for each test. It is good laboratory practice and important to read the entire product insert before you begin testing. Be sure the product insert is current for the test system in use, the correct specimen type is used, the proper reagents (testing solutions) are added in the correct order, and the test is performed according to the step by step procedure outlined in the product insert. Some waived tests also have quick reference instructions included, which are cards or small signs containing diagrams or flow charts with essential steps for conducting testing. Be sure that quick reference instructions are current for the test system in use and are available to the individuals performing the test.

It is important to follow the manufacturer’s instructions for quality control. If the guidelines use words such as “suggested”, “should”, or “may”, CLIA has determined that this means required.

It is good laboratory practice to document training and competency for anyone performing waived testing.

Below are some common questions asked about Waived testing taken from the government website. These are questions most commonly asked related to this type of testing.

I AM A PHYSICIAN PERFORMING URINE DIP STICKS AND FINGER STICKS FOR BLOOD GLUCOSE IN MY OFFICE AS PART OF THE PATIENT’S VISIT. AM I CONSIDERED TO HAVE A LABORATORY AND DO I NEED A CLIA CERTIFICATE?

Yes, the testing you perform qualifies as waived laboratory testing and you need a CLIA Certificate of Waiver. This testing requires a CLIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances.

WHEN CAN I START PERFORMING THE WAIVED TESTING?

After you apply for your certificate, you will receive a fee coupon assessing a fee. Follow the instructions on the fee coupon for payment. After CMS receives your payment, your certificate will be mailed to you. You may begin testing once you have received your certificate. You also need to check with your State Agency since some states have additional requirements.

HOW DO I KNOW IF I HAVE CURRENT MANUFACTURER’S INSTRUCTIONS?

Always use the product insert or quick reference instructions that come with the test system you just opened. If you are unsure whether you have current instructions, contact the manufacturer at the telephone number listed in the product insert.

WHY IS IT IMPORTANT TO FOLLOW THE CURRENT MANUFACTURER’S INSTRUCTIONS?

It is important to always follow the current test system’s instructions precisely to be sure your results are accurate. This includes performing any quality control procedures that the manufacturer recommends or requires. Over time, a manufacturer may make modifications to a test system that result in changes to the instructions. Failure to use the current instructions could cause inaccurate results that may result in a misdiagnosis or delay in proper treatment of a patient.

DO I NEED TO FOLLOW ALL THE MANUFACTURER’S INSTRUCTIONS ON HOW TO PERFORM THE TEST? Yes, all the information in the test product insert instructions is considered part of the manufacturer’s instructions and must be followed. Some examples of this information are:

● Observing storage and handling requirements for the test system components;

● Adhering to the expiration date of the test system and reagents, as applicable;

● Performing quality control, as required by the manufacturer;

● Performing function checks and maintenance of equipment;

● Training testing personnel in the performance of the test, if required by the manufacturer;

● Reporting patients’ test results in the units described in the package insert;

● Sending specimens for confirmatory tests, when required by the manufacturer; and

● Ensuring that any test system limitations are observed.

CAN I FOLLOW THE QUICK REFERENCE GUIDE INSTEAD OF FOLLOWING THE PRODUCT INSERT?

No, the quick reference guide is only a synopsis of the entire product insert.

AS A LABORATORY DIRECTOR, WHAT KINDS OF THINGS CAN I DO TO HELP ASSURE THE ACCURACY AND RELIABILITY OF THE WAIVED TESTING IN MY LABORATORY? In order to assure the accuracy and reliability of waived testing in your laboratory, you should develop and maintain good laboratory practices. Some examples are listed below:

● Provide specific training to the testing personnel so that you are certain they:

● Collect specimens appropriately;

● Label and store specimens appropriately;

● Understand and then follow the manufacturer’s instructions for each test performed;

● Know how to perform the testing;

● Know how to document and communicate the test results; and

● Are able to identify inaccurate results or test system failures.

● Observe and evaluate your testing personnel to make certain the testing is accurate.

● Do they positively identify the patient and specimen?

● Do they collect a proper specimen?

● Do they know how the specimen should be preserved, if applicable?

● If the specimen needs to be transported, do your testing personnel understand and adhere to the transport requirements?

● Check for extreme changes in such things as humidity, temperature, or lighting; as these may affect test results.

● Make sure that the patient specimen is handled properly from collection to test completion.