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Frequently Asked Questions

Frequently Asked Questions

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If I only perform waived testing, am I required to perform PT?

PT is not required for any test that is waived. Please refer to the FDA web site to determine whether your test(s) are waived.

However, enrolling in a PT program and performing PT on your waived test(s) will provide you with an excellent indication of the accuracy of the waived test(s) and thus improve the quality of testing you provide to your patients. It also serves to demonstrate the accuracy of your testing if it is ever questioned.


How do I enroll in Bacteriology?

Your laboratory must enroll for a total of five PT samples per testing event and those five samples must include at least one of the types of testing your laboratory performs – Gram stains, direct antigen, identification of organisms, and/or susceptibility testing.

If you perform one or two of these procedures, the five samples must include the one or two tests you perform.

Call your PT program; the PT representatives will help you enroll properly. Assisting you with proper enrollment is a CLIA requirement for approved PT programs.


If I have more than one testing site, do I need to enroll in PT for each site?

PT enrollment and participation are required for each CLIA certificate. 

If you have a separate certificate for each site and perform non-waived testing at each site, you must enroll in PT for the tests performed at each site.

If you offer non-waived testing at each site, but you transport the testing to a main laboratory or central laboratory, you must enroll in an approved PT program for all the “regulated” analytes covered under that certificate, not for each site.


Are there ever circumstances in PT that require my laboratory to verify the accuracy of 'regulated' tests?
  1. When your results are submitted to the program after the deadline and are considered a late submission, your laboratory grade will be zero. If you did not test your PT samples at all, your laboratory grade will be zero.
  2. There are instances when your grade does not reflect your performance because there was no consensus among all laboratories performing the PT sample(s).  If you did not test your PT samples at all, your laboratory grade will be zero.
  3. There are instances when your grade does not reflect your performance because there was no consensus among all laboratories performing the PT sample(s). You will see this identified by the PT program as “ungradable” on your results report. You will be assigned an artificial score of “100%”, noted as “ungradeable”, but that does NOT reflect your performance.

If I do not successfully participate in PT what happens?

If your laboratory has never had an unsuccessful performance for any PT analyte, subspecialty, or specialty, the CLIA regulations, the laboratory will be issued a Statement of Deficiencies (SOD-CMS 2567 form).

  • The laboratory director implements a plan of correction and signs page one of the 2567 form.
  • This is submitted to the State Agency within the required time frame.

However, repeated unsuccessful PT performance for that same analyte, subspecialty or specialty may result in your laboratory no longer being allowed to perform the failed testing.

  • The laboratory will be issued a Statement of Deficiencies (SOD-CMS 2567 form) and a letter from the central office of CMS to voluntary cease testing.
  • The laboratory director implements a plan of correction and signs page one of the 2567 form.  
  • The laboratory must pass two (off schedule) PT events before the laboratory would be in complaiance and able to resume testing.

My laboratory has been required to cease testing an unsuccessful analyte, subspecialty or specialty. What must we do to be able to resume testing?

First, you must demonstrate that your laboratory has identified the reason(s) for your unsuccessful performance and corrected it (them). Be sure to document this process.

Secondly, when you are certain you have corrected the problem(s), your laboratory must perform two consecutive PT events (re-instatement PT) successfully, which will demonstrate correction of the problem(s).

If you have been required to cease testing, your Medicare and Medicaid reimbursement will be suspended for a six month period. However, you may purchase your re-instatement PT events at any time after you have identified and corrected the problem(s) that caused the unsuccessful performance. You should purchase these samples from your PT program, but you may obtain them from any CMS approved PT program.

You may decide to voluntarily stop testing the unsuccessful analyte, subspecialty, or specialty.

As soon as you receive your PT results indicating an unsuccessful performance, you must notify your regional office CLIA consultant that testing of the unsuccessful analyte, subspecialty, or specialty has been stopped voluntarily.

This notification must be made before you receive a letter from your CMS regional office imposing a cease testing sanction.

You will need to successfully perform two consecutive PT events for the analyte, subspecialty, or specialty that was unsuccessful.

Your Medicare and Medicaid reimbursement will not be affected.